The following data is part of a premarket notification filed by Taut, Inc. with the FDA for Intraducer.
| Device ID | K921934 | 
| 510k Number | K921934 | 
| Device Name: | INTRADUCER | 
| Classification | Catheter, Irrigation | 
| Applicant | TAUT, INC. 2571 KANEVILLE COURT Geneva, IL 60134 | 
| Contact | Kenseth | 
| Correspondent | Kenseth TAUT, INC. 2571 KANEVILLE COURT Geneva, IL 60134 | 
| Product Code | GBX | 
| CFR Regulation Number | 878.4200 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1992-04-24 | 
| Decision Date | 1992-07-15 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  INTRADUCER  73051157  1028559 Live/Registered | TAUT, INC. 1975-05-01 |