The following data is part of a premarket notification filed by Sorex Medical with the FDA for Picc-fix.
| Device ID | K911070 |
| 510k Number | K911070 |
| Device Name: | PICC-FIX |
| Classification | Device, Intravascular Catheter Securement |
| Applicant | SOREX MEDICAL 5725 WEST HAROLD GATTY DR. Salt Lake City, UT 84116 |
| Contact | Joseph Sorenson |
| Correspondent | Joseph Sorenson SOREX MEDICAL 5725 WEST HAROLD GATTY DR. Salt Lake City, UT 84116 |
| Product Code | KMK |
| CFR Regulation Number | 880.5210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-11 |
| Decision Date | 1991-07-05 |