The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Resolve Biliary Drainage Catheter.
Device ID | K063733 |
510k Number | K063733 |
Device Name: | RESOLVE BILIARY DRAINAGE CATHETER |
Classification | Stents, Drains And Dilators For The Biliary Ducts |
Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
Contact | Amy Mckinney |
Correspondent | Amy Mckinney MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
Product Code | FGE |
CFR Regulation Number | 876.5010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2006-12-18 |
Decision Date | 2007-11-14 |
Summary: | summary |