Submission Details
| 510(k) Number | K152560 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 09, 2015 |
| Decision Date | October 23, 2015 |
| Days to Decision | 44 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
K152560 is an FDA 510(k) clearance for the Bard Snare Retrieval Kit, a Device, Percutaneous Retrieval (Class II — Special Controls, product code MMX), submitted by Neometrics, Inc. (Plymouth, US). The FDA issued a Cleared decision on October 23, 2015, 44 days after receiving the submission on September 9, 2015. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.5150.
| 510(k) Number | K152560 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 09, 2015 |
| Decision Date | October 23, 2015 |
| Days to Decision | 44 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 |