Amplatz Heparin Coated Catheter
FDA 510(k)Class II (US FDA 510(k))
by Cook, Inc.
Identifiers
- 510(k) Number
- K832178 FDA 510(k)
- FDA Product Code
- DQY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Amplatz Heparin Coated Catheter is a percutaneous catheter designed for use in vascular procedures. It features a heparin coating intended to reduce thrombogenicity and minimize clot formation during vascular interventions.
This device is identified by FDA 510(k) number K832178 and is classified under product code DQY. It has received FDA 510(k) clearance as a substantially equivalent device.
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: AMPLATZ HEPARIN COATED CATHETER (K832178) - FDA 510 (k), AMPLATZ HEPARIN COATED CATHETER (K832178) — FDA 510 (k) | Innolitics, Amplatz Heparin Coated Catheter - Cook | FDA Evidence Review, AMPLATZ HEPARIN COATED CATHETER 510 (k) K832178 - FDA.report
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K832178 | Class II | Active |
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Manufacturer
- Manufacturer
- Cook, Inc.
Sources (1)
- FDA 510(k) K832178 24 fields · synced Sep 25, 2026