The following data is part of a premarket notification filed by Daig Corp. with the FDA for Pacel(tm) Flow Directed Pacing Catheter.
| Device ID | K914185 |
| 510k Number | K914185 |
| Device Name: | 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 | 1991-09-18 |
| Decision Date | 1992-01-27 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414734022521 | K914185 | 000 |
| 05414734021906 | K914185 | 000 |
| 05414734007856 | K914185 | 000 |
| 05414734001045 | K914185 | 000 |