The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Passage Hemostasis Valve.
| Device ID | K143429 |
| 510k Number | K143429 |
| Device Name: | Passage Hemostasis Valve |
| Classification | Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass |
| Applicant | MERIT MEDICAL SYSTEMS, INC. PARKMORE BUSINESS PARK WEST Galway, IE |
| Contact | Mark Mullaney |
| Correspondent | Siobhan King MERIT MEDICAL SYSTEMS, INC. PARKMORE BUSINESS PARK WEST Galway, IE |
| Product Code | DTL |
| CFR Regulation Number | 870.4290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-12-01 |
| Decision Date | 2014-12-22 |
| Summary: | summary |