FDA 510(k), K180023, WIRION

FDA 510(k), K180023, WIRION

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510(K) Number: K180023
Device Name: WIRION
Manufacturer: Gardia Medical Ltd.
Device Classification Name: temporary carotid catheter for embolic capture
Regulation Number: 870.1250
Classification Product Code: NTE
Date Received: 01/03/2018
Decision Date: 03/21/2018
Regulation Medical Specialty: Cardiovascular

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