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 |