K112892 is an FDA 510(k) clearance for the IMPELLA 2.5 PLUS CATHETER..
Submitted by Abiomed, Inc. (Danvers, US). The FDA issued a Cleared decision on September 6, 2012, 342 days after receiving the submission on September 30, 2011.
This device falls under the Cardiovascular FDA review panel.
| 510(k) Number | K112892 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | September 30, 2011 |
| Decision Date | September 06, 2012 |
| Days to Decision | 342 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | PBL |
| Device Class | - |