The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Torque Device.
| Device ID | K936032 |
| 510k Number | K936032 |
| Device Name: | TORQUE DEVICE |
| Classification | Wire, Guide, Catheter |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 79 WEST 4500 SOUTH SUITE 9 Salt Lake City, UT 84107 |
| Contact | Dennis Reigle |
| Correspondent | Dennis Reigle MERIT MEDICAL SYSTEMS, INC. 79 WEST 4500 SOUTH SUITE 9 Salt Lake City, UT 84107 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-12-17 |
| Decision Date | 1994-03-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450007812 | K936032 | 000 |
| 10884450007799 | K936032 | 000 |