510(k) K193507
K193507 is an FDA 510(k) premarket notification submitted by Merit Medical Systems, Inc. for the device "Merit ONE Snare System". The FDA issued a decision of Substantially Equivalent on January 17, 2020. The device falls under product code MMX (Device, Percutaneous Retrieval), a Class II device regulated under 21 CFR 870.5150. Merit Medical Systems, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 2020
- Date Received
- December 18, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Device, Percutaneous Retrieval
- Device Class
- Class II
- Regulation Number
- 870.5150
- Review Panel
- CV
- Submission Type