The following data is part of a premarket notification filed by Daig Corp. with the FDA for Modified Label To Percu. Intro. W/sideport & 3-way.
| Device ID | K894430 |
| 510k Number | K894430 |
| Device Name: | MODIFIED LABEL TO PERCU. INTRO. W/SIDEPORT & 3-WAY |
| Classification | Introducer, Catheter |
| Applicant | DAIG CORP. 14901 DEVEAU PLACE Minnetonka, MN 55345 -2126 |
| Contact | J Fleischhacker |
| Correspondent | J 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 | 1989-07-17 |
| Decision Date | 1989-08-09 |