The following data is part of a premarket notification filed by Daig Corp. with the FDA for Ultra-flex Hemostasis Introducer. Model 406xxx.
| Device ID | K994334 |
| 510k Number | K994334 |
| Device Name: | ULTRA-FLEX HEMOSTASIS INTRODUCER. MODEL 406XXX |
| Classification | Introducer, Catheter |
| Applicant | DAIG CORP. 14901 DEVEAU PLACE Minnetonka, MN 55345 -2126 |
| Contact | Todd Kornmann |
| Correspondent | Todd Kornmann DAIG CORP. 14901 DEVEAU PLACE Minnetonka, MN 55345 -2126 |
| Product Code | DYB |
| CFR Regulation Number | 870.1340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-23 |
| Decision Date | 2000-05-15 |
| Summary: | summary |