The following data is part of a premarket notification filed by Clarus Medical Systems, Inc. with the FDA for Clarus Cholangiogram Catheter Kit.
Device ID | K925742 |
510k Number | K925742 |
Device Name: | CLARUS CHOLANGIOGRAM CATHETER KIT |
Classification | Catheter, Cholangiography |
Applicant | CLARUS MEDICAL SYSTEMS, INC. 2605 FERNBROOK LA Minneapolis, MN 55447 |
Contact | Gregory J Mathison |
Correspondent | Gregory J Mathison CLARUS MEDICAL SYSTEMS, INC. 2605 FERNBROOK LA Minneapolis, MN 55447 |
Product Code | GBZ |
CFR Regulation Number | 878.4200 [🔎] |
Decision | Substantially Equivalent - Kit (SESK) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-11-13 |
Decision Date | 1993-06-01 |