The following data is part of a premarket notification filed by Cardiosolutions with the FDA for Cariosolutions Percu-pro Steerable Introdcer 65cm Cariosolutions Percu-pro Steerable Introducer 80cm.
| Device ID | K120086 |
| 510k Number | K120086 |
| Device Name: | CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODCER 65CM CARIOSOLUTIONS PERCU-PRO STEERABLE INTRODUCER 80CM |
| Classification | Catheter, Steerable |
| Applicant | CARDIOSOLUTIONS 375 WEST ST. West Bridgewater, MA 02379 |
| Contact | Michele Lucey |
| Correspondent | Michele Lucey CARDIOSOLUTIONS 375 WEST ST. West Bridgewater, MA 02379 |
| Product Code | DRA |
| CFR Regulation Number | 870.1280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-11 |
| Decision Date | 2012-04-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10864795000136 | K120086 | 000 |
| 10864795000105 | K120086 | 000 |