The following data is part of a premarket notification filed by North American Instrument Corp. with the FDA for Morse Hemostatic Catheter Introducer Set.
| Device ID | K915078 |
| 510k Number | K915078 |
| Device Name: | MORSE HEMOSTATIC CATHETER INTRODUCER SET |
| Classification | Introducer, Catheter |
| Applicant | NORTH AMERICAN INSTRUMENT CORP. Glens Falls, NY 12801 |
| Contact | James Welsh |
| Correspondent | James Welsh NORTH AMERICAN INSTRUMENT CORP. Glens Falls, NY 12801 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-08 |
| Decision Date | 1992-06-10 |