The following data is part of a premarket notification filed by Evalve Inc with the FDA for Steerable Guide Catheter.
| Device ID | K083793 |
| 510k Number | K083793 |
| Device Name: | STEERABLE GUIDE CATHETER |
| Classification | Catheter, Steerable |
| Applicant | EVALVE INC 4045 CAMPBELL AVENUE Menlo Park, CA 94025 |
| Contact | Karuna Velusamy |
| Correspondent | Karuna Velusamy EVALVE INC 4045 CAMPBELL AVENUE Menlo Park, CA 94025 |
| Product Code | DRA |
| CFR Regulation Number | 870.1280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-22 |
| Decision Date | 2009-04-27 |
| Summary: | summary |