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 | K122088 |
| 510k Number | K122088 |
| Device Name: | MERIT ONE SNARE SYSTEM |
| Classification | Device, Percutaneous Retrieval |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Contact | Mark Mullaney |
| Correspondent | Mark Mullaney MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Product Code | MMX |
| CFR Regulation Number | 870.5150 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-16 |
| Decision Date | 2012-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20884450121270 | K122088 | 000 |
| 10884450681722 | K122088 | 000 |
| 10884450681821 | K122088 | 000 |
| 10884450681708 | K122088 | 000 |
| 10884450572129 | K122088 | 000 |
| 10884450094812 | K122088 | 000 |
| 10884450094829 | K122088 | 000 |
| 10884450094836 | K122088 | 000 |
| 10884450094867 | K122088 | 000 |
| 10884450094874 | K122088 | 000 |
| 10884450094881 | K122088 | 000 |
| 10884450094898 | K122088 | 000 |
| 10884450094904 | K122088 | 000 |
| 10884450094911 | K122088 | 000 |
| 10884450094973 | K122088 | 000 |
| 10884450681746 | K122088 | 000 |