The following data is part of a premarket notification filed by Heartport, Inc. with the FDA for Heartport Thoracic Trocar.
| Device ID | K964302 |
| 510k Number | K964302 |
| Device Name: | HEARTPORT THORACIC TROCAR |
| Classification | Trocar |
| Applicant | HEARTPORT, INC. 200 CHESAPEAKE DR. Redwood City, CA 94063 |
| Contact | Marianne C Drennan |
| Correspondent | Marianne C Drennan HEARTPORT, INC. 200 CHESAPEAKE DR. Redwood City, CA 94063 |
| Product Code | DRC |
| CFR Regulation Number | 870.1390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-29 |
| Decision Date | 1997-05-09 |
| Summary: | summary |