The following data is part of a premarket notification filed by Jet Medical, Inc. with the FDA for Jet Power Injectable Picc.
| Device ID | K180546 |
| 510k Number | K180546 |
| Device Name: | Jet Power Injectable PICC |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | Jet Medical, Inc. 97 Main Street Schwenksville, PA 19473 |
| Contact | Courtney Nix |
| Correspondent | Courtney Nix Medcomp (dba Medical Components, Inc.) 1499 Delp Drive Harleysville, PA 19438 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-03-01 |
| Decision Date | 2018-11-21 |
| Summary: | summary |