The following data is part of a premarket notification filed by Daig Corp. with the FDA for Alliance Left Heart Delivery System Introducer, Model #407509.
| Device ID | K000004 |
| 510k Number | K000004 |
| Device Name: | ALLIANCE LEFT HEART DELIVERY SYSTEM INTRODUCER, MODEL #407509 |
| Classification | Introducer, Catheter |
| Applicant | DAIG CORP. 14901 DEVEAU PLACE Minnetonka, MN 55345 -2126 |
| Contact | Paul Cornelison |
| Correspondent | Paul Cornelison 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 | 2000-01-03 |
| Decision Date | 2000-11-29 |