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 |