The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for In-line Hemostasis Valve.
| Device ID | K990975 |
| 510k Number | K990975 |
| Device Name: | IN-LINE HEMOSTASIS VALVE |
| Classification | Introducer, Catheter |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Contact | Chester Mccoy |
| Correspondent | Chester Mccoy MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-03-23 |
| Decision Date | 2000-03-15 |
| Summary: | summary |