The following data is part of a premarket notification filed by Medcomp with the FDA for Medcomp P-cath.
| Device ID | K953811 |
| 510k Number | K953811 |
| Device Name: | MEDCOMP P-CATH |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | MEDCOMP 1499 DELP DR. Harleysville, PA 19438 |
| Contact | Michelle Demers |
| Correspondent | Michelle Demers MEDCOMP 1499 DELP DR. Harleysville, PA 19438 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-26 |
| Decision Date | 1996-07-25 |