Identifiers
- 510(k) Number
- K962668 FDA 510(k)
- FDA Product Code
- DXC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.4450 FDA 510(k)
- Regulation Number
- 870.4450 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Amr-Acv Clamps are vascular clamps, a line extension to an existing vascular clamp model. They are designed to provide consistent vessel occlusion. The clamps have a low profile and are available in various sizes.
The Amr-Acv Clamps are supplied in 5 models with sizes ranging from 45mm to 100mm. They have been subject to an FDA 510(k) premarket notification, with clearance type listed as Traditional and a decision description of Substantially Equivalent.
Frequently asked questions
What are the AMR-ACV Clamps used for?
The AMR-ACV Clamps are used for vascular occlusion, providing consistent vessel closure.
How many models and sizes are available?
The AMR-ACV Clamps are supplied in 5 models with sizes ranging from 45mm to 100mm.
What is the regulatory status of the AMR-ACV Clamps?
The AMR-ACV Clamps have been subject to an FDA 510(k) premarket notification, with a decision description of Substantially Equivalent.
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: AMR-ACV CLAMPS by APPLIED MEDICAL RESOURCES | FDA 510(k) Summary, Amr-acv Clamps 510 (k) FDA Premarket Notification K962668 APPLIED ..., AMR-ACV CLAMPS (K962668) — FDA 510(k) | Innolitics, Surgical Clamps | Applied Medical
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K962668 | Class II | Active |
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Manufacturer
- Manufacturer
- Applied Medical Resources
Sources (1)
- FDA 510(k) K962668 24 fields · synced Sep 25, 2026