K961992 is an FDA 510(k) clearance for the NEEDLE'S EYE SNARE. This device is classified as a Catheter, Embolectomy (Class II - Special Controls, product code DXE).
Submitted by Cook Pacemaker Corp. (Leechburg, US). The FDA issued a Cleared decision on December 27, 1996, 220 days after receiving the submission on May 21, 1996.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5150.
| 510(k) Number | K961992 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 21, 1996 |
| Decision Date | December 27, 1996 |
| Days to Decision | 220 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DXE — Catheter, Embolectomy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5150 |