The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for One Snare Endovascular Microsnare System.
| Device ID | K142265 |
| 510k Number | K142265 |
| Device Name: | ONE Snare Endovascular Microsnare System |
| Classification | Device, Percutaneous Retrieval |
| Applicant | MERIT MEDICAL SYSTEMS, INC. PARKMORE BUSINESS PARK WEST Galway, IE |
| Contact | Mark Mullaney |
| Correspondent | Siobhan King MERIT MEDICAL SYSTEMS, INC. PARKMORE BUSINESS PARK WEST Galway, IE |
| Product Code | MMX |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-08-15 |
| Decision Date | 2014-11-13 |
| Summary: | summary |