The following data is part of a premarket notification filed by Sorex Medical with the FDA for Picc Insertion Kit/p.i.c. & Picc Exchang Kit/p.e.k.
| Device ID | K910315 |
| 510k Number | K910315 |
| Device Name: | PICC INSERTION KIT/P.I.C. & PICC EXCHANG KIT/P.E.K |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| 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 | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-01-24 |
| Decision Date | 1991-04-05 |