The following data is part of a premarket notification filed by Medcomp with the FDA for 3f X 60 Cm Single Lumen Silisone Vascu-picc, 4f X 60cm Single Lumen Silicone Vascu-picc, 5f X 60 Cm Single Lumen Silicon.
| Device ID | K030270 |
| 510k Number | K030270 |
| Device Name: | 3F X 60 CM SINGLE LUMEN SILISONE VASCU-PICC, 4F X 60CM SINGLE LUMEN SILICONE VASCU-PICC, 5F X 60 CM SINGLE LUMEN SILICON |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | MEDCOMP 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Meghan J Tintle |
| Correspondent | Meghan J Tintle MEDCOMP 1499 DELP DR. 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 | 2003-01-27 |
| Decision Date | 2003-04-11 |
| Summary: | summary |