The following data is part of a premarket notification filed by Cardiosolutions Inc with the FDA for Percu-pro Guidewire.
| Device ID | K094062 |
| 510k Number | K094062 |
| Device Name: | PERCU-PRO GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| 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 | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-12-31 |
| Decision Date | 2010-09-27 |
| Summary: | summary |