Home › Device types › DRE
Dilator, Vessel, For Percutaneous Catheterization
FDA product code DRE · Class 2 · Cardiovascular
2,203
Registered devices
3,156
Adverse events
40
Recalls
105
510(k) clearances
Devices with this code
NRG RF Transseptal Kit — Baylis Médicale Cie IncPrelude PRO™ — Merit Medical Systems, Inc.Prelude® — Merit Medical Systems, Inc.AVANTI+ — CORDIS CORPORATIONMerit S-MAK™ — Merit Medical Systems, Inc.Prelude® PRO — Merit Medical Systems, Inc.Prelude PRO™ — Merit Medical Systems, Inc.PAC Kit/5 Catheter Introducer Kit — ARGON MEDICAL DEVICES, INC.Amplatz — COOK INCORPORATEDAmplatz — COOK INCORPORATEDMEDCOMP VESSEL DILATORMEDCOMP VESSEL DILATOR — Medical Components, Inc.Cook — COOK INCORPORATEDCatapult Guide Sheath — Contract Medical International GmbHPrelude PRO™ — Merit Medical Systems, Inc.Catapult Guide Sheath — Contract Medical International GmbHPrelude PRO™ — Merit Medical Systems, Inc.Argyle — Mozarc Medical US LLCPrelude® — Merit Medical Systems, Inc.Prelude® PRO — Merit Medical Systems, Inc.Micropuncture — COOK INCORPORATEDPrelude® — Merit Medical Systems, Inc.AVANTI — CORDIS CORPORATIONAmplatz — COOK INCORPORATEDAngioDynamics — NAVILYST MEDICAL, INC.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-06-01 | Argon Medical Devices, Inc | Kits containing Lidocaine HCL Injection USP 1% 10mg/mL 5mL ampules subject to another recall recalled due to not meeting release criteria for sterility. |
| 2025-03-27 | Galt Medical Corporation | Due to a potential open seal in the sterile barrier packaging . |
| 2024-08-12 | Merit Medical Systems, Inc. | 7F sheath introducers labeled as 7.5F |
| 2024-01-30 | Angiodynamics, Inc. | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through th |
| 2024-01-30 | Angiodynamics, Inc. | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through th |
| 2024-01-30 | Angiodynamics, Inc. | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through th |
| 2024-01-30 | Angiodynamics, Inc. | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through th |
| 2024-01-30 | Angiodynamics, Inc. | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through th |
| 2024-01-30 | Angiodynamics, Inc. | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through th |
| 2024-01-30 | Angiodynamics, Inc. | Non-conformance may prevent the guidewire from passing through the introducer hub during a surgical procedure. The inability of the guidewire to pass through th |
Query this across every FDA database — by API.
Linked GUDID · 510(k)/PMA · MAUDE · recalls · establishments. Free tier, no card required.
Get your free API keyRead the docsSourced from public U.S. FDA data. Informational only — not medical or regulatory advice. Not affiliated with the FDA.