DQYFDA Class 2 · 21 CFR 870.1250
Catheter, Percutaneous
Device family · Cardiovascular
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
888
Manufacturers
125
Flagged signals
19
Adverse-event reports
36,925
Code matrix
| FDA product code | DQY |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1250 |
| GMDN | 35386 |
| Implantable | No |
| Life-sustaining | No |
Adverse-event signals
Public · always freeMAUDE disproportionality (PRR), flagged where PRR ≥ 2, χ² ≥ 4, count ≥ 3.
| Event type | Year | Reports | PRR | χ² |
|---|---|---|---|---|
| Other | 2010 | 13 | 665.2 | 7,979 |
| Other | 2012 | 4 | 443.4 | 1,353 |
| Other | 2012 | 4 | 241.8 | 735 |
| Other | 2011 | 6 | 221.7 | 1,108 |
| Other | 2012 | 5 | 184.7 | 740 |
| Death | 2012 | 3 | 31.0 | 60 |
| Death | 2010 | 3 | 16.2 | 29 |
| Death | 2010 | 5 | 10.0 | 32 |
| Death | 2021 | 4 | 9.5 | 23 |
| Death | 2022 | 3 | 6.4 | 9 |
| Death | 2011 | 3 | 6.0 | 8 |
| Death | 2025 | 5 | 5.3 | 13 |
| Death | 2011 | 3 | 4.9 | 6 |
| Death | 2010 | 3 | 4.5 | 5 |
| Death | 2012 | 10 | 4.4 | 23 |
| Death | 2019 | 4 | 4.0 | 6 |
| Death | 2012 | 6 | 2.6 | 5 |
| Death | 2022 | 18 | 2.4 | 14 |
| Death | 2024 | 17 | 2.3 | 11 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 36,925 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Medtronic Vascular | 31 | 2023 | — |
| Biotronik, Inc. | 23 | 2024 | — |
| Cordis Corp. | 21 | 2002 | — |
| Vascular Solutions, Inc. | 21 | 2018 | — |
| Cook, Inc. | 20 | 2014 | — |
| ASAHI INTECC CO., LTD. | 19 | 2024 | — |
| Advanced Cardiovascular Systems, Inc. | 19 | 2000 | — |
| Concentric Medical, Inc. | 18 | 2014 | — |
| Scimed Life Systems, Inc. | 17 | 1998 | — |
| Microvention, Inc. | 16 | 2023 | — |
| C.R. Bard, Inc. | 14 | 2022 | — |
| Boston Scientific Corp | 13 | 2012 | — |
| Medtronic, Inc. | 13 | 2025 | — |
| Guidant Corp. | 13 | 2003 | — |
| Abbott Medical | 12 | 2026 | — |
| NUMED, INC. | 12 | 2012 | — |
| Arrow Intl., Inc. | 11 | 2009 | — |
| Medtronics Interventional Vascular | 11 | 1999 | — |
| St Jude Medical | 11 | 2014 | — |
| BOSTON SCIENTIFIC CORPORATION | 11 | 2024 | 0.14 |
| PENUMBRA, INC. | 10 | 2020 | — |
| Target Therapeutics | 10 | 1995 | — |
| Spectranetics Corp. | 10 | 2011 | — |
| Quinton, Inc. | 9 | 1989 | — |
| Codman & Shurtleff, Inc. | 8 | 2019 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
Amplatzer TorqVue Delivery System · Abbott510(k) · 2026-04-24
Teleport Glide Microcatheter · OrbusNeich Medical (Shenzhen) Co., Ltd.510(k) · 2026-04-10
Amplatzer Trevisio Intravascular Delivery System; 9-ATV06F45/609-ATV07F45/609-ATV07F45/809-ATV08F45/609-ATV08F45/809-ATV09F45/809-ATV10F45/809-ATV12F45/80 · ABBOTT MEDICAL510(k) · 2026-03-13
C320LBB Delivery System (C320LBBS45), C320LBB Delivery System (C320LBBS48), C320LBB Delivery System (C320LBBL45), C320LBB Delivery System (C320LBBL48) · Medtronic, Inc.510(k) · 2025-12-19
Amplatzer Piccolo Delivery System (9-PDS-04F-045) · ABBOTT MEDICAL510(k) · 2025-12-17
Telescope Guide Extension Catheter · Medtronic, Ireland510(k) · 2025-10-29
CPS Locator 3D Delivery Catheter · Centerpoint Systems510(k) · 2025-08-22
CoraForce Microcatheter, CoraFlex Microcatheter · Reflow Medical, Inc.510(k) · 2025-08-22
Primum Hydrophilic Guiding Catheter · Pendracare510(k) · 2025-06-29
CPS Locator 3D Plus Delivery Catheter · CenterPoint Systems, LLC510(k) · 2025-06-27
SAT CenterFlow Molding Balloon Catheter (IN20-00313) · Strait Access Technologies Holdings510(k) · 2025-06-25
FlexiGo 3D Delivery Catheter · CenterPoint Systems, LLC510(k) · 2025-06-18
Dorado PTA Balloon Dilatation Catheter · Bard Peripheral Vascular, Inc.510(k) · 2025-06-17
GORE® Tri-Lobe Balloon Catheter · W. L. Gore & Associates, Inc.510(k) · 2025-06-02
Shockwave CS Guide Catheter · Shockwave Medical, Inc.510(k) · 2025-05-02
APRO 45 Catheter · Alembic, LLC510(k) · 2025-05-01
APRO 55 Intermediate Catheter · Alembic, LLC510(k) · 2025-04-29
Amulet Steerable Delivery Sheath · ABBOTT MEDICAL510(k) · 2025-04-25
FlowGuide (FG60F); GuidionShort (GS60F) · Imds Operations B.V.510(k) · 2025-04-17
LiquID .051 LP Guide Catheter Extension · Seigla Medical, Inc.510(k) · 2025-04-04
SelectSite C304 Deflectable Catheter System (C304); C315 Delivery System (C315) · Medtronic, Inc.510(k) · 2025-03-27
Seclusion Catheter · Basis Medical510(k) · 2025-02-28
Ventrax Delivery System · Merit Medical Systems, Inc.510(k) · 2025-01-15
COREPASS Modular Microcatheter (FLEX); COREPASS Modular Microcatheter (CONTROL) · OrbusNeich Medical (Shenzhen) Co., Ltd.510(k) · 2025-01-07
MitraClip G5 Steerable Guide Catheter (SGC0801); TriClip G5 Steerable Guide Catheter (TSGC0801) · ABBOTT MEDICAL510(k) · 2024-12-31
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.