The following data is part of a premarket notification filed by Daig Corp. with the FDA for Daig Pacel(tm) Flow Directed Pacing Catheter.
| Device ID | K890794 |
| 510k Number | K890794 |
| Device Name: | DAIG PACEL(TM) FLOW DIRECTED PACING CATHETER |
| Classification | Electrode, Pacemaker, Temporary |
| 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 | LDF |
| CFR Regulation Number | 870.3680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-02-17 |
| Decision Date | 1989-06-20 |