The following data is part of a premarket notification filed by Cardiosolutions Inc with the FDA for Cardiosolutions Percu-pro Steerable Introducer.
| Device ID | K131332 |
| 510k Number | K131332 |
| Device Name: | CARDIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER |
| Classification | Introducer, Catheter |
| Applicant | CARDIOSOLUTIONS INC 375 WEST STREET Massachusetts, MA 02379 |
| Contact | Michele Luce |
| Correspondent | Michele Luce CARDIOSOLUTIONS INC 375 WEST STREET Massachusetts, MA 02379 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-09 |
| Decision Date | 2013-07-19 |
| Summary: | summary |