The following data is part of a premarket notification filed by Medcomp with the FDA for 1.9f X 20cm Vascu-picc, 1.9f X 50cm Vascu-picc, Model Vpi.9s20, Vpi.9s50.
| Device ID | K091466 |
| 510k Number | K091466 |
| Device Name: | 1.9F X 20CM VASCU-PICC, 1.9F X 50CM VASCU-PICC, MODEL VPI.9S20, VPI.9S50 |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | MEDCOMP 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Susan Pileggi |
| Correspondent | Susan Pileggi MEDCOMP 1499 DELP DR. Harleysville, PA 19438 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-05-18 |
| Decision Date | 2009-06-17 |
| Summary: | summary |