The following data is part of a premarket notification filed by Heartport, Inc. with the FDA for Heartport Handswitch Electrocautery Probe.
| Device ID | K961334 |
| 510k Number | K961334 |
| Device Name: | HEARTPORT HANDSWITCH ELECTROCAUTERY PROBE |
| Classification | Electrosurgical, Cutting & Coagulation & Accessories |
| 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 | GEI |
| CFR Regulation Number | 878.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-08 |
| Decision Date | 1996-11-15 |
| Summary: | summary |