The following data is part of a premarket notification filed by Heartport, Inc. with the FDA for Heartport Thoracic Surgical Trocars: (tost-4-3, Tostl-6-3, Ton-4-2 And Tonl-6-2.
| Device ID | K961463 |
| 510k Number | K961463 |
| Device Name: | HEARTPORT THORACIC SURGICAL TROCARS: (TOST-4-3, TOSTL-6-3, TON-4-2 AND TONL-6-2 |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | HEARTPORT, INC. 200 CHESAPEAKE DR. Redwood City, CA 94063 |
| Contact | Isabella R Abati |
| Correspondent | Isabella R Abati HEARTPORT, INC. 200 CHESAPEAKE DR. Redwood City, CA 94063 |
| Product Code | GCJ |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-17 |
| Decision Date | 1996-10-08 |
| Summary: | summary |