Submission Details
| 510(k) Number | K060915 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | April 04, 2006 |
| Decision Date | April 17, 2007 |
| Days to Decision | 378 days |
| Submission Type | Traditional |
| Review Panel | Neurology (NE) |
| Summary | Summary PDF |
Cleared
Traditional
KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS
Apr 2007
Decision
378d
Days
Class 2
Risk
About This 510(k) Submission
K060915 is an FDA 510(k) clearance for the KIRWAN L-ANEURYSM CLIPS AND APPLIER, KIRWAN YASARGIL-TYPE ANEURYSM CLIPS AND APPLIERS, a Clip, Aneurysm (Class II — Special Controls, product code HCH), submitted by Kirwan Surgical Products, Inc. (Marshfield, US). The FDA issued a Cleared decision on April 17, 2007, 378 days after receiving the submission on April 4, 2006. 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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