K091921 is an FDA 510(k) clearance for the CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP. This device is classified as a Clip, Aneurysm (Class II - Special Controls, product code HCH).
Submitted by Codman & Shurtleff, Inc. (Raynham, US). The FDA issued a Cleared decision on September 8, 2009, 70 days after receiving the submission on June 30, 2009.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5200.
| 510(k) Number | K091921 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 30, 2009 |
| Decision Date | September 08, 2009 |
| Days to Decision | 70 days |
| Submission Type | Special |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
| Product Code | HCH - Clip, Aneurysm |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 882.5200 |