The following data is part of a premarket notification filed by Daig Corp. with the FDA for Response(tm) Steerable Catheter.
| Device ID | K913940 |
| 510k Number | K913940 |
| Device Name: | RESPONSE(TM) STEERABLE CATHETER |
| Classification | Catheter, Steerable |
| 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 | DRA |
| CFR Regulation Number | 870.1280 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-09-03 |
| Decision Date | 1993-01-26 |