The following data is part of a premarket notification filed by Medex, Inc. with the FDA for Mx 339 Twin Hemostatic Y Connector.
| Device ID | K912709 |
| 510k Number | K912709 |
| Device Name: | MX 339 TWIN HEMOSTATIC Y CONNECTOR |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | MEDEX, INC. 3637 LACON RD. Hillard, OH 43026 |
| Contact | Cathy Chenetski |
| Correspondent | Cathy Chenetski MEDEX, INC. 3637 LACON RD. Hillard, OH 43026 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-06-19 |
| Decision Date | 1991-09-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 50351688508025 | K912709 | 000 |
| 50351688508377 | K912709 | 000 |
| 50351688510035 | K912709 | 000 |