The following data is part of a premarket notification filed by Daig Corp. with the FDA for Daig Electrophysiology Catheter W/infusion Lumen.
| Device ID | K914278 |
| 510k Number | K914278 |
| Device Name: | DAIG ELECTROPHYSIOLOGY CATHETER W/INFUSION LUMEN |
| Classification | Catheter, Electrode Recording, Or Probe, Electrode Recording |
| 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 | DRF |
| CFR Regulation Number | 870.1220 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-24 |
| Decision Date | 1992-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05414734201223 | K914278 | 000 |
| 05414734201209 | K914278 | 000 |
| 05414734201193 | K914278 | 000 |
| 05414734201186 | K914278 | 000 |
| 05414734201179 | K914278 | 000 |