K021606 is an FDA 510(k) clearance for the EN-SNARE ENDOVASCULAR SNARE AND CATHETER. This device is classified as a Device, Percutaneous Retrieval (Class II - Special Controls, product code MMX).
Submitted by Medical Device Technologies, Inc. (Gainesville, US). The FDA issued a Cleared decision on May 31, 2002, 15 days after receiving the submission on May 16, 2002.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5150.
| 510(k) Number | K021606 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 16, 2002 |
| Decision Date | May 31, 2002 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | MMX — Device, Percutaneous Retrieval |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.5150 |