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 |