The following data is part of a premarket notification filed by Medical Components, Inc. with the FDA for Cup Monitoring Kit Cvpk-14.
| Device ID | K854984 |
| 510k Number | K854984 |
| Device Name: | CUP MONITORING KIT CVPK-14 |
| Classification | Catheter, Percutaneous |
| Applicant | MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Anthony Madison |
| Correspondent | Anthony Madison MEDICAL COMPONENTS, INC. 1499 DELP DR. Harleysville, PA 19438 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-12 |
| Decision Date | 1986-03-31 |