The following data is part of a premarket notification filed by Circulatory Technology, Inc. with the FDA for The V Bag, Catalog Number Vb1800; Vac-box For Vacuum Assisted Venous Drainage, Catalog Number Vacbox1500.
| Device ID | K012942 |
| 510k Number | K012942 |
| Device Name: | THE V BAG, CATALOG NUMBER VB1800; VAC-BOX FOR VACUUM ASSISTED VENOUS DRAINAGE, CATALOG NUMBER VACBOX1500 |
| Classification | Reservoir, Blood, 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 | DTN |
| CFR Regulation Number | 870.4400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-08-31 |
| Decision Date | 2001-11-05 |