The following data is part of a premarket notification filed by Medical Components, Inc. with the FDA for Medcomp C.a.v.h. Catheter.
Device ID | K862771 |
510k Number | K862771 |
Device Name: | MEDCOMP C.A.V.H. CATHETER |
Classification | Catheter, Femoral |
Applicant | MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville, PA 19438 |
Contact | Rachel D Richardson |
Correspondent | Rachel D Richardson MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville, PA 19438 |
Product Code | LFK |
CFR Regulation Number | 876.5540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-07-22 |
Decision Date | 1986-08-06 |