The following data is part of a premarket notification filed by Heartport, Inc. with the FDA for Directflow Kit, 24 Fr, Softclamp Kit, 24fr, Straightshot Kit, 23 Fr, Straight Tip, Straightshot Kit, 23 Fr, Angled Tip.
| Device ID | K994243 |
| 510k Number | K994243 |
| Device Name: | DIRECTFLOW KIT, 24 FR, SOFTCLAMP KIT, 24FR, STRAIGHTSHOT KIT, 23 FR, STRAIGHT TIP, STRAIGHTSHOT KIT, 23 FR, ANGLED TIP |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-16 |
| Decision Date | 2000-05-05 |
| Summary: | summary |