K043041 is an FDA 510(k) clearance for the AESCULAP T-BAR ANEURYSM CLIPS (TITANIUM & PHYNOX). This device is classified as a Clip, Aneurysm (Class II - Special Controls, product code HCH).
Submitted by Aesculap, Inc. (Center Valley, US). The FDA issued a Cleared decision on December 9, 2004, 35 days after receiving the submission on November 4, 2004.
This device falls under the Neurology FDA review panel. Regulated under 21 CFR 882.5200.
| 510(k) Number | K043041 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 04, 2004 |
| Decision Date | December 09, 2004 |
| Days to Decision | 35 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 |