Device Classification Name |
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
|
510(k) Number |
K120980 |
Device Name |
1.9F X 20CM VASCU-PICC 1.9F X 50CM VASCU-PICC |
Applicant |
MEDICAL COMPONENTS INC |
1499 DELP DRIVE |
HARLEYSVILLE,
PA
19438
|
|
Applicant Contact |
JEAN CALLOW |
Correspondent |
MEDICAL COMPONENTS INC |
1499 DELP DRIVE |
HARLEYSVILLE,
PA
19438
|
|
Correspondent Contact |
JEAN CALLOW |
Regulation Number | 880.5970
|
Classification Product Code |
|
Date Received | 04/02/2012 |
Decision Date | 05/02/2012 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Statement |
Statement
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|