The following data is part of a premarket notification filed by Medical Components Inc with the FDA for Medcomp Vascu-picc & Midline Catheters.
| Device ID | K121094 |
| 510k Number | K121094 |
| Device Name: | MEDCOMP VASCU-PICC & MIDLINE CATHETERS |
| 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 | 2012-04-10 |
| Decision Date | 2012-06-06 |