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 | K141408 |
| 510k Number | K141408 |
| Device Name: | RESOLVE BILIARY LOCKING 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 | Glen Norton |
| Correspondent | Glenn Norton 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 | 2014-05-28 |
| Decision Date | 2014-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450313302 | K141408 | 000 |
| 10884450057466 | K141408 | 000 |
| 10884450057459 | K141408 | 000 |
| 10884450012823 | K141408 | 000 |
| 10884450012816 | K141408 | 000 |
| 10884450012809 | K141408 | 000 |
| 10884450012793 | K141408 | 000 |
| 10884450086039 | K141408 | 000 |
| 10884450414757 | K141408 | 000 |
| 10884450057831 | K141408 | 000 |
| 10884450076702 | K141408 | 000 |
| 10884450683924 | K141408 | 000 |
| 10884450685157 | K141408 | 000 |
| 10884450685133 | K141408 | 000 |
| 10884450685126 | K141408 | 000 |
| 10884450683917 | K141408 | 000 |
| 10884450683900 | K141408 | 000 |
| 10884450683894 | K141408 | 000 |
| 10884450057473 | K141408 | 000 |
| 10884450057480 | K141408 | 000 |
| 10884450313296 | K141408 | 000 |
| 10884450313289 | K141408 | 000 |
| 10884450313272 | K141408 | 000 |
| 10884450313265 | K141408 | 000 |
| 10884450313258 | K141408 | 000 |
| 10884450313241 | K141408 | 000 |
| 10884450313234 | K141408 | 000 |
| 10884450086022 | K141408 | 000 |
| 10884450071516 | K141408 | 000 |
| 10884450071509 | K141408 | 000 |
| 10884450057848 | K141408 | 000 |
| 10884450057565 | K141408 | 000 |
| 10884450057558 | K141408 | 000 |
| 10884450057534 | K141408 | 000 |
| 10884450057527 | K141408 | 000 |
| 10884450057503 | K141408 | 000 |
| 10884450057497 | K141408 | 000 |
| 10884450685140 | K141408 | 000 |