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510(k) Data Aggregation
K Number
K972867Device Name
CRAFT DUO-VAC SUCTION UNIT, CRAFT SUCTION UNIT
Manufacturer
Date Cleared
1997-10-24
(81 days)
Product Code
Regulation Number
864.1850Why did this record match?
Product Code :
ICX
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
Provide Low flow regulated negative pressure for general suction and aspiration.
Device Description
The Craft™ Suction Pumps have been developed to provide a smooth low volume vacuum at variable negative pressure. The device has the same technological characteristics as the predicate device. vacuum being activated by a foot operatual switch controlled by the surgeon. The range of vacuyum being variable from 0-4.50mmHg and adjustable over this range by a pre-set control. Vacuum is provided by a quiet diaphringm pump, working from a mains voltage supply (USA I IOV 60Hz). An overflow bottle provides a mensure of safety to prevent aspirated fluids being drawn into the vacuum power unit. The tran also acting us a reservoir to provide an even vacuum pressure during procedures, The foot control has an air-operated solennid, switching the main purnp unit. No electrical connections are made to the sealed foot operated control.
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