Identifiers
- 510(k) Number
- K092563 FDA 510(k)
- FDA Product Code
- DTL FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4290 FDA 510(k)
- Regulation Number
- 870.4290 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Gator ClipSeal Plug is a flexible polymer device classified as an adaptor, stopcock, manifold, or fitting for cardiopulmonary bypass procedures. It functions as a hemostatic seal within 12F to 24F introducer sheaths to control blood loss during interventional procedures.
This single-use device is designed to maintain a secure seal around 0.035-inch or 0.038-inch guidewires within specified sheath sizes. Supplied sterile, it is intended for use in vascular access applications and has received FDA 510(k) clearance under the Traditional pathway. No MRI safety information or reusable variants are indicated in the specifications.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Vascular Solutions, Inc. 8280 Gator® clipseal plug - RevMed, GATOR CLIPSEAL PLUG (K092563) — FDA 510 (k) | Innolitics, AccessGUDID - DEVICE: Gator® clipseal plug (M20682800), Gator® clipseal plug - The GATOR is intended to be used with 12F to 24F ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K092563 | Class II | Active |
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Manufacturer
- Manufacturer
- Vascular Solutions, Inc.
Sources (1)
- FDA 510(k) K092563 24 fields · synced Sep 19, 2026