The following data is part of a premarket notification filed by Cook Incorporated with the FDA for Advance Biliary Balloon Catheter.
| Device ID | K173414 |
| 510k Number | K173414 |
| Device Name: | Advance Biliary Balloon Catheter |
| Classification | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection |
| Applicant | Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 |
| Contact | Colin Jacob |
| Correspondent | Hui (alice) Ouyang Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 |
| Product Code | GCA |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-01 |
| Decision Date | 2018-06-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10827002588049 | K173414 | 000 |
| 10827002588032 | K173414 | 000 |