The following data is part of a premarket notification filed by Merit Medical Systems, Inc. with the FDA for Merit One Snare System.
| Device ID | K193507 |
| 510k Number | K193507 |
| Device Name: | Merit ONE Snare System |
| Classification | Device, Percutaneous Retrieval |
| Applicant | Merit Medical Systems, Inc. Parkmore Business Park West Galway, IE |
| Contact | Mark Mullaney |
| Correspondent | Michael O'sullivan Merit Medical Systems, Inc. Parkmore Business Park West Galway, IE |
| Product Code | MMX |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-18 |
| Decision Date | 2020-01-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450392604 | K193507 | 000 |