The following data is part of a premarket notification filed by Cardiosolutions Inc with the FDA for Percupro Messenger Balloon Catheter.
| Device ID | K094048 |
| 510k Number | K094048 |
| Device Name: | PERCUPRO MESSENGER BALLOON CATHETER |
| Classification | Catheter, Flow Directed |
| Applicant | CARDIOSOLUTIONS INC 75 MILL STREET Stoughton, MA 02072 |
| Contact | Michele Lucey |
| Correspondent | Michele Lucey CARDIOSOLUTIONS INC 75 MILL STREET Stoughton, MA 02072 |
| Product Code | DYG |
| CFR Regulation Number | 870.1240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-31 |
| Decision Date | 2011-07-14 |
| Summary: | summary |