The following data is part of a premarket notification filed by Circulatory Technology, Inc. with the FDA for Better-venter.
| Device ID | K961594 |
| 510k Number | K961594 |
| Device Name: | BETTER-VENTER |
| Classification | Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Applicant | CIRCULATORY TECHNOLOGY, INC. 21 SINGWORTH ST. Oyster Bay, NY 11771 |
| Contact | Yehuda Tamari |
| Correspondent | Yehuda Tamari CIRCULATORY TECHNOLOGY, INC. 21 SINGWORTH ST. Oyster Bay, NY 11771 |
| Product Code | DWF |
| CFR Regulation Number | 870.4210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-04-24 |
| Decision Date | 1996-09-05 |