The following data is part of a premarket notification filed by Taut, Inc. with the FDA for Taut Balloon Catheter, Model 50640.
| Device ID | K011018 |
| 510k Number | K011018 |
| Device Name: | TAUT BALLOON CATHETER, MODEL 50640 |
| Classification | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection |
| Applicant | TAUT, INC. 2571 KANEVILLE COURT Geneva, IL 60134 |
| Contact | Ron Kenseth |
| Correspondent | Ron Kenseth TAUT, INC. 2571 KANEVILLE COURT Geneva, IL 60134 |
| Product Code | GCA |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-04 |
| Decision Date | 2001-06-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 24026704418910 | K011018 | 000 |