The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Squirt Model Number Fds100.
| Device ID | K981417 |
| 510k Number | K981417 |
| Device Name: | SQUIRT MODEL NUMBER FDS100 |
| Classification | Catheter, Continuous Flush |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Contact | Dennis D Reigle |
| Correspondent | Dennis D Reigle MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-04-20 |
| Decision Date | 1998-07-17 |
| Summary: | summary |