MiniGuard Arterial Safety Valve— 510(k) K182442
Substantially EquivalentQuest Medical, Inc.
FDA 510(k) clearance K182442 for MiniGuard Arterial Safety Valve, Substantially Equivalent on 2018-11-06. Applicant: Quest Medical, Inc.. Device class: 2.
Clearance details
- Applicant
- Quest Medical, Inc.
- Product code
- Code MJJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.4400
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Allen, TX, US
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