DREFDA Class 2 · 21 CFR 870.1310
Dilator, Vessel, For Percutaneous Catheterization
Device family · Cardiovascular
Automated profile from regulatory + adverse-event registries · AI-reviewed · expert clinical sign-off in progress — not yet independently verified.
FDA clearances
104
Manufacturers
27
Flagged signals
12
Adverse-event reports
2,547
Code matrix
| FDA product code | DRE |
| Device class | Class 2 |
| Regulation | 21 CFR 870.1310 |
| GMDN | — (crosswalk pending) |
| 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 |
|---|---|---|---|---|
| Death | 2020 | 10 | 9.7 | 70 |
| Death | 2012 | 4 | 5.5 | 11 |
| Death | 2021 | 5 | 4.9 | 12 |
| Death | 2023 | 9 | 4.9 | 24 |
| Death | 2021 | 5 | 4.9 | 12 |
| Death | 2015 | 3 | 4.1 | 4 |
| Death | 2022 | 4 | 3.9 | 6 |
| Death | 2024 | 4 | 3.9 | 6 |
| Death | 2019 | 4 | 3.9 | 6 |
| Death | 2018 | 4 | 3.9 | 6 |
| Death | 2024 | 7 | 3.8 | 12 |
| Death | 2025 | 6 | 3.2 | 7 |
Device-level recall linkage pending an FDA-recalls product-code re-ingest. Class 2 family · 2,547 total adverse-event reports.
Manufacturer landscape
| Manufacturer | Clearances | Latest | Concern |
|---|---|---|---|
| Merit Medical Systems, Inc. | 9 | 2025 | — |
| Quinton, Inc. | 3 | 1986 | — |
| COOK INCORPORATED | 3 | 2021 | 0.23 |
| Togo Medikit Co., Ltd. | 3 | 2020 | — |
| GALT MEDICAL CORP. | 3 | 2019 | — |
| NAVILYST MEDICAL, INC. | 2 | 2013 | — |
| Spectranetics Corp. | 2 | 2014 | — |
| Uresil Corp. | 2 | 1998 | — |
| Mallinckrodt Critical Care | 1 | 1984 | — |
| Cordis Corp. | 1 | 1997 | — |
| Shiley, Inc. | 1 | 1988 | — |
| Lifetech Scientific (Shenzhen) Co., Ltd. | 1 | 2013 | — |
| Datascope Corp. | 1 | 1990 | — |
| Medrad, Inc. | 1 | 1983 | — |
| Honeywell, Inc. | 1 | 1981 | — |
| Vascular Solutions, Inc. | 1 | 2016 | — |
| Medical Components, Inc. | 1 | 1980 | — |
| CARDIACASSIST, INC. | 1 | 2017 | — |
| Sorin Group Italia S.r.L. | 1 | 2025 | — |
| PROCEDURE PRODUCTS, INC. | 1 | 1981 | — |
| Boston Scientific Corp | 1 | 1998 | — |
| Abbott Vascular, Inc. | 1 | 2007 | — |
| Edwards Lifesciences, LLC | 1 | 2010 | — |
| Daig Corp. | 1 | 1989 | — |
| HANSEN MEDICAL, INC. | 1 | 2008 | — |
Concern score lights up where a maker maps to a scored entity (depth fast-follow).
Recent FDA clearances
ProtekDilate Vascular Access Kit · Sorin Group Italia S.R.L.510(k) · 2025-12-19
VersaCross Connect Transseptal Dilator · Baylis Medical Company, Inc.510(k) · 2025-05-29
Micro Ace Gold Advanced Micro Access System · Merit Medical Systems, Inc.510(k) · 2025-01-15
VersaCross Connect Transseptal Dilator · Baylis Medical Company, Inc.510(k) · 2024-07-12
VersaCross Connect Transseptal Dilator · Baylis Medical Company, Inc.510(k) · 2023-12-14
Micro Ace Advanced Micro Access System · Merit Medical Systems, Inc.510(k) · 2023-09-27
TightRail Guardian Motorized Dilator Sheath, 9 French (575-009); TightRail Guardian Motorized Dilator Sheath, 11 French (575-011); TightRail Guardian Motorized Dilator Sheath, 13 French (575-013) · Spectranetics, Inc.510(k) · 2022-12-15
TightRail Guardian Motorized Dilator Sheath · Spectranetics, Inc.510(k) · 2022-08-24
Xtractor device · Xcardia Innovation , Ltd.510(k) · 2022-02-17
Endovascular Dilator and Sets · Cook Incorporated510(k) · 2021-04-06
ExpanSure Large Access Transseptal Dilator · Baylis Medical Company, Inc.510(k) · 2020-06-12
MEDRON Vessel Dilator - 6F x 22cm HDPE Dilator, MEDRON Vessel Dilator - 15.5F - 17.5F HDPE Dilator · Medron, LLC510(k) · 2020-05-06
Super Sheath · Togo Medikit Co., Ltd.510(k) · 2020-03-19
Sterile Dilator · Galt Medical Corp.510(k) · 2019-09-26
S-MAK XL · Merit Medical Systems, Inc.510(k) · 2019-04-10
ExpanSure Transseptal Dilation System · Baylis Medical Company, Inc.510(k) · 2019-03-21
Dilator Sets · Cook Incorporated510(k) · 2018-12-20
MC3 Vascular Access Kit 21030 · Mc3 Incorporated510(k) · 2018-10-29
Coaxial Dilator Set (Micro-Introducer) · Galt Medical Corp.510(k) · 2017-10-16
Medcomp Vessel Dilator · Medcomp ( Medical Components)510(k) · 2017-06-01
van Andel Dilatation Catheter · Cook Incorporated510(k) · 2017-04-28
Protek Duo Venous Dilator Set, Protek Solo Venous Dilator Set · Cardiacassist, Inc.510(k) · 2017-01-06
VSI StraitSet micro-introducer kit · Vascular Solutions, Inc.510(k) · 2016-08-11
Sheath Introducer · Bioteque Corp.510(k) · 2016-07-22
TightRail Sub-C Rotating Dilator Sheath · Spectranetics, Inc.510(k) · 2016-07-08
Sources: FDA 510(k)/PMA · openFDA MAUDE · FDA device classification · MedevIQ manufacturer-canonical. Registry data, AI-reviewed; expert clinical sign-off in progress.