Merit ONE Snare System
FDA 510(k) K193507 · Merit Medical Systems, Inc.
510(k) numberK193507
Submission
- Device name
- Merit ONE Snare System
- Applicant
- Merit Medical Systems, Inc.
Galway, IE - Received
- December 18, 2019
- Decision date
- January 17, 2020
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- MMX – Device, Percutaneous Retrieval
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5150
- Specialty
- Cardiovascular
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Questions and answers
When was Merit ONE Snare System cleared by the FDA?
Merit ONE Snare System (K193507) received a 510(k) decision of Substantially Equivalent on January 17, 2020, 30 days after the submission was received.
What is the product code of K193507?
The FDA product code is MMX – Device, Percutaneous Retrieval, a Class II (moderate risk) device regulated under 21 CFR 870.5150.