The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Hemostasis Valve.
| Device ID | K072556 |
| 510k Number | K072556 |
| Device Name: | HEMOSTASIS VALVE |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Contact | Shirley Hyink |
| Correspondent | Shirley Hyink MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-09-10 |
| Decision Date | 2007-11-20 |
| Summary: | summary |