The following data is part of a premarket notification filed by Daig Corp. with the FDA for Daig Electrophysiology Catheter.
Device ID | K894500 |
510k Number | K894500 |
Device Name: | DAIG ELECTROPHYSIOLOGY CATHETER |
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 | 1989-07-19 |
Decision Date | 1989-09-18 |