Home › Device types › OFL
Percutaneous Sheath Introducer Kit
FDA product code OFL · Class 2 · Cardiovascular
437
Registered devices
47
Adverse events
5
Recalls
0
510(k) clearances
Devices with this code
Micro-Introducer Kit — GALT MEDICAL CORP.Stiffen Micro-Introducer Kit — GALT MEDICAL CORP.Pediatric Tearaway Introducer Kit — GALT MEDICAL CORP.Transitionless Micro-Introducer Kit — GALT MEDICAL CORP.Elite Transitionless Micro-Introducer Kit — GALT MEDICAL CORP.Valved Tearaway Kit — GALT MEDICAL CORP.Micro-Access Tearaway Introducer Kit — GALT MEDICAL CORP.GaltStick Introducer Kit — GALT MEDICAL CORP.Valved Tearaway Kit — GALT MEDICAL CORP.Elite Transitionless Micro-Introducer Kit — GALT MEDICAL CORP.Typenex Introducer Set — TYPENEX MEDICAL LLCSeamless™ — B. BRAUN MEDICAL INC.Percutaneous Micro-Introducer Kit — ARGON MEDICAL DEVICES, INC.Tearaway Introducer Kit — GALT MEDICAL CORP.Split Sheath Introducer Kit — ARGON MEDICAL DEVICES, INC.Micro-Introducer Kit — GALT MEDICAL CORP.Stiffen Micro-Introducer Kit — GALT MEDICAL CORP.Tearaway Introducer Kit — GALT MEDICAL CORP.Micro-Access Tearaway Introducer Kit — GALT MEDICAL CORP.Micro-Introducer Kit — GALT MEDICAL CORP.Elite Transitionless Micro-Introducer Kit — GALT MEDICAL CORP.Micro-Access Tearaway Introducer Kit — GALT MEDICAL CORP.1 Piece Introducer w/ Micro Set — ARGON MEDICAL DEVICES, INC.STRADIS — STRADIS MEDICAL, LLC
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2026-04-21 | ARROW INTERNATIONAL, LLC | Lidocaine, Bupivacaine, and 0.9% sodium chloride, the subject of a supplier recall, were included into kits and sets. The supplier was found to have quality iss |
| 2026-03-11 | ARROW INTERNATIONAL, LLC | Due to receiving a notice from a supplier that the liquid adhesive was incorrectly manufactured |
| 2025-03-27 | Galt Medical Corporation | Due to a potential open seal in the sterile barrier packaging. |
| 2025-03-27 | Galt Medical Corporation | Due to a potential open seal in the sterile barrier packaging. |
| 2022-11-02 | Stradis Medical, LLC dba Stradis Healthcare | Medical and surgical procedure trays and kits underwent certain manufacturing conditions that may result in the outer bag being incompletely sealed, which may r |
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