The following data is part of a premarket notification filed by Heartport, Inc. with the FDA for Heartport Endopulmonary Vent Catheter.
| Device ID | K981009 |
| 510k Number | K981009 |
| Device Name: | HEARTPORT ENDOPULMONARY VENT CATHETER |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | HEARTPORT, INC. 700 BAY RD. Redwood City, CA 94063 |
| Contact | Marianne D Drennan |
| Correspondent | Marianne D Drennan HEARTPORT, INC. 700 BAY RD. Redwood City, CA 94063 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-03-18 |
| Decision Date | 1998-09-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103182866 | K981009 | 000 |