The following data is part of a premarket notification filed by Origin Medsystems, Inc. with the FDA for Origin Cardiac Stablizer Occluder.
| Device ID | K970611 |
| 510k Number | K970611 |
| Device Name: | ORIGIN CARDIAC STABLIZER OCCLUDER |
| Classification | Clamp, Vascular |
| Applicant | ORIGIN MEDSYSTEMS, INC. 135 CONSTITUTION DR. Menlo Park, CA 94025 |
| Contact | Anthony Durso |
| Correspondent | Anthony Durso ORIGIN MEDSYSTEMS, INC. 135 CONSTITUTION DR. Menlo Park, CA 94025 |
| Product Code | DXC |
| CFR Regulation Number | 870.4450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-18 |
| Decision Date | 1997-08-19 |
| Summary: | summary |