The following data is part of a premarket notification filed by Heartport, Inc. with the FDA for Heartport Introducer Sheath.
| Device ID | K972570 |
| 510k Number | K972570 |
| Device Name: | HEARTPORT INTRODUCER SHEATH |
| Classification | Introducer, Catheter |
| 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 | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-10 |
| Decision Date | 1997-10-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103190816 | K972570 | 000 |