Home › Device types › DRE
Dilator, Vessel, For Percutaneous Catheterization
FDA product code DRE · Class 2 · Cardiovascular
2,219
Registered devices
3,205
Adverse events
40
Recalls
105
510(k) clearances
Devices with this code
EDWARDS OXIMETRY CENTRAL VENOUS CATHETER — Edwards Lifesciences LLCPrelude® — Merit Medical Systems, Inc.Axcess Pediatric Cath Lab Introducer Kit — ARGON MEDICAL DEVICES, INC.TorFlex Transseptal Guiding Sheath — Baylis Médicale Cie IncNA — B BRAUN INTERVENTIONAL SYSTEMS, INCCOMPASS ™ — B BRAUN INTERVENTIONAL SYSTEMS, INCAVANTI — Cordis US Corp.PRESEP — Edwards Lifesciences LLCTorFlex Transseptal Guiding Sheath — Baylis Médicale Cie IncMerit MAK™ — Merit Medical Systems, Inc.SightRail Manual Dilator Sheath — Spectranetics CorporationNRG RF Transseptal Kit — Baylis Médicale Cie IncMEDCOMP VESSEL DILATORMEDCOMP VESSEL DILATOR — Medical Components, Inc.Vaxcel Mini Stick — Angiodynamics, Inc.Prelude® PRO — Merit Medical Systems, Inc.AVANTI — CORDIS CORPORATIONCatapult Guide Sheath — Contract Medical International GmbHTorFlex Transseptal Guiding Sheath — Baylis Médicale Cie IncAVANTI — CORDIS CORPORATIONIntroducer Kit w/ AMC/4 Needle — ARGON MEDICAL DEVICES, INC.Prelude Roadster™ — Merit Medical Systems, Inc.NA — B BRAUN INTERVENTIONAL SYSTEMS, INCTorFlex Transseptal Guiding Sheath — Baylis Médicale Cie IncVersaCross Large Access Solution — Baylis Médicale Cie 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 |
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