The following data is part of a premarket notification filed by Heartport, Inc. with the FDA for Quickdraw Venous Cannula.
| Device ID | K981995 |
| 510k Number | K981995 |
| Device Name: | QUICKDRAW VENOUS CANNULA |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | HEARTPORT, INC. 700 BAY RD. Redwood City, CA 94063 |
| Contact | Marianne C Drennan |
| Correspondent | Marianne C 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 | 1998-06-08 |
| Decision Date | 1999-04-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00690103182705 | K981995 | 000 |
| 00690103182699 | K981995 | 000 |