The following data is part of a premarket notification filed by Evalve Inc with the FDA for Modificaton To: Steerable Guide Catheter, Model Sgc01st.
| Device ID | K100789 |
| 510k Number | K100789 |
| Device Name: | MODIFICATON TO: STEERABLE GUIDE CATHETER, MODEL SGC01ST |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-03-22 |
| Decision Date | 2010-04-21 |
| Summary: | summary |