The following data is part of a premarket notification filed by Universal Medical Instrument Corp. with the FDA for Pci W/cath-seal Side Flow Fitting.
| Device ID | K842259 |
| 510k Number | K842259 |
| Device Name: | PCI W/CATH-SEAL SIDE FLOW FITTING |
| Classification | Introducer, Catheter |
| Applicant | UNIVERSAL MEDICAL INSTRUMENT CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-07 |
| Decision Date | 1984-08-01 |