Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit
FDA 510(k) K191758 · Argon Medical Devices, Inc.
510(k) numberK191758
Submission
- Device name
- Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit
- Applicant
- Argon Medical Devices, Inc.
Athens, TX, US - Received
- July 1, 2019
- Decision date
- December 17, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 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 Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit cleared by the FDA?
Single-Loop Snare Retrieval Kit, Triple-Loop Snare Retrieval Kit (K191758) received a 510(k) decision of Substantially Equivalent on December 17, 2019, 169 days after the submission was received.
What is the product code of K191758?
The FDA product code is MMX – Device, Percutaneous Retrieval, a Class II (moderate risk) device regulated under 21 CFR 870.5150.