The following data is part of a premarket notification filed by Cathlab Corp. with the FDA for Cathlab Silicone Biliary Balloon Catheter.
| Device ID | K910917 |
| 510k Number | K910917 |
| Device Name: | CATHLAB SILICONE BILIARY BALLOON CATHETER |
| Classification | Biliary Catheter For Stone Removal That May Also Allow For Irrigation And Contrast Injection |
| Applicant | CATHLAB CORP. 17991 FITCH Irvine, CA 92714 |
| Contact | Daniel R Lucas |
| Correspondent | Daniel R Lucas CATHLAB CORP. 17991 FITCH Irvine, CA 92714 |
| Product Code | GCA |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-03-05 |
| Decision Date | 1991-08-02 |