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FDA 510(k), K141617, CLEANER ROTATIONAL THROMBECTOMY SYSTEM
FDA 510(k), K141617, CLEANER ROTATIONAL THROMBECTOMY SYSTEM
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510(K) Number: K141617
Device Name: CLEANER ROTATIONAL THROMBECTOMY SYSTEM
Manufacturer: SUSAN D GOLDSTEIN-FALK
Device Classification Name: Peripheral Mechanical Thrombectomy With Aspiration
Regulation Number: QEW
Classification Product Code: KXA
Date Received: 06/17/2014
Decision Date: 11/14/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: CLEANER ROTATIONAL THROMBECTOMY SYSTEM
Manufacturer: SUSAN D GOLDSTEIN-FALK
Device Classification Name: Peripheral Mechanical Thrombectomy With Aspiration
Regulation Number: QEW
Classification Product Code: KXA
Date Received: 06/17/2014
Decision Date: 11/14/2014
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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