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FDA 510(k), K162027, TRAcelet Compression Device
FDA 510(k), K162027, TRAcelet Compression Device
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510(K) Number: K162027
Device Name: TRAcelet Compression Device
Manufacturer: COLLEEN MULLINS
Device Classification Name: Clamp, Vascular
Regulation Number: DXC
Classification Product Code: KXA
Date Received: 07/22/2016
Decision Date: 10/21/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: TRAcelet Compression Device
Manufacturer: COLLEEN MULLINS
Device Classification Name: Clamp, Vascular
Regulation Number: DXC
Classification Product Code: KXA
Date Received: 07/22/2016
Decision Date: 10/21/2016
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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