The following data is part of a premarket notification filed by Circulatory Technology, Inc. with the FDA for Initary Better Bladder-pediatric.
| Device ID | K140321 |
| 510k Number | K140321 |
| Device Name: | INITARY BETTER BLADDER-PEDIATRIC |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-02-18 |
| Decision Date | 2014-04-17 |
| Summary: | summary |