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 |