Submission Details
| 510(k) Number | K091921 FDA.gov |
| FDA Decision | Cleared 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 |
Cleared
Special
CODMAN ANEURYSM CLIPS, CODMAN AVM MICRO CLIP SYSTEM, CODMAN SLIM-LINE GRAFT, REINFORCING, MINI ANEURYSM CLIP
Sep 2009
Decision
70d
Days
Class 2
Risk
About This 510(k) Submission
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, 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 review panel. Regulated under 21 CFR 882.5200.
Device Classification
| Product Code | HCH — Clip, Aneurysm |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 882.5200 |
Manufacturer
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