The following data is part of a premarket notification filed by Merit Medical Systems Inc with the FDA for En Snare Endovascular Snare System.
| Device ID | K151497 |
| 510k Number | K151497 |
| Device Name: | EN Snare Endovascular Snare 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-06-04 |
| Decision Date | 2015-07-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450269203 | K151497 | 000 |
| 10884450453022 | K151497 | 000 |
| 10884450452438 | K151497 | 000 |
| 10884450452483 | K151497 | 000 |
| 10884450452452 | K151497 | 000 |
| 10884450452469 | K151497 | 000 |
| 10884450452476 | K151497 | 000 |
| 10884450033163 | K151497 | 000 |
| 10884450033170 | K151497 | 000 |
| 10884450033187 | K151497 | 000 |
| 10884450033194 | K151497 | 000 |
| 10884450033200 | K151497 | 000 |
| 10884450033217 | K151497 | 000 |
| 10884450033224 | K151497 | 000 |
| 10884450452421 | K151497 | 000 |