The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Resolve Biliary Locking Drainage Catheter.
| Device ID | K121832 |
| 510k Number | K121832 |
| Device Name: | RESOLVE BILIARY LOCKING DRAINAGE CATHETER |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1111 South Velasco St Angleton, TX 77515 |
| Contact | Casey Hughes |
| Correspondent | Casey Hughes MERIT MEDICAL SYSTEMS, INC. 1111 South Velasco St Angleton, TX 77515 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-06-22 |
| Decision Date | 2012-07-17 |
| Summary: | summary |