K152136 is an FDA 510(k) clearance for the Recovery Cone Removal System. This device is classified as a Device, Percutaneous Retrieval (Class II - Special Controls, product code MMX).
Submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on February 18, 2016, 202 days after receiving the submission on July 31, 2015.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.5150.
| 510(k) Number | K152136 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 2015 |
| Decision Date | February 18, 2016 |
| Days to Decision | 202 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 |