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 | K092343 |
| 510k Number | K092343 |
| Device Name: | EN SNARE ENDOVASCULAR SNARE SYSTEM |
| Classification | Device, Percutaneous Retrieval |
| Applicant | MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. South Jordan, UT 84095 |
| Contact | Glenn Norton |
| Correspondent | Glenn Norton 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 | 2009-08-04 |
| Decision Date | 2009-08-07 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10884450146924 | K092343 | 000 |
| 20884450146914 | K092343 | 000 |
| 10884450146900 | K092343 | 000 |