The following data is part of a premarket notification filed by Medical Components Inc with the FDA for 2.6f X 20cm Vascu-picc 2.6f X 50cm Vascu-picc.
Device ID | K120981 |
510k Number | K120981 |
Device Name: | 2.6F X 20CM VASCU-PICC 2.6F 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 |