The following data is part of a premarket notification filed by Daig Corp. with the FDA for Percutaneous Introducer W/side Port 3 Way Stopcock.
| Device ID | K870374 |
| 510k Number | K870374 |
| Device Name: | PERCUTANEOUS INTRODUCER W/SIDE PORT 3 WAY STOPCOCK |
| Classification | Introducer, Catheter |
| Applicant | DAIG CORP. 14901 DEVEAU PLACE Minnetonka, MN 55345 -2126 |
| Contact | John Fleischhacker |
| Correspondent | John Fleischhacker DAIG CORP. 14901 DEVEAU PLACE Minnetonka, MN 55345 -2126 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-29 |
| Decision Date | 1987-03-18 |