The following data is part of a premarket notification filed by Medical Components Inc with the FDA for 1.9f X 20cm Vascu-picc 1.9f X 50cm Vascu-picc.
| Device ID | K120980 |
| 510k Number | K120980 |
| Device Name: | 1.9F X 20CM VASCU-PICC 1.9F X 50CM VASCU-PICC |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | MEDICAL COMPONENTS INC 1499 DELP DRIVE Harleysville, PA 19438 |
| Contact | Jean Callow |
| Correspondent | Jean Callow MEDICAL COMPONENTS INC 1499 DELP DRIVE 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 | 2012-04-02 |
| Decision Date | 2012-05-02 |