The following data is part of a premarket notification filed by Coeur, Inc. with the FDA for Disposable Hemostatic Y-connectors.
| Device ID | K113132 |
| 510k Number | K113132 |
| Device Name: | DISPOSABLE HEMOSTATIC Y-CONNECTORS |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | COEUR, INC. 100 PHYSICIANS WAY SUITE 200 Lebanon, TN 37090 |
| Contact | Debra F Manning |
| Correspondent | Debra F Manning COEUR, INC. 100 PHYSICIANS WAY SUITE 200 Lebanon, TN 37090 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-24 |
| Decision Date | 2012-01-20 |