ClearanceBrief
510(k) K002186 ยท DPW Flowmeter, Blood, Cardiovascular

VASCULAR ASSIST

ApplicantHuntleigh Healthcare, Inc., Eatontown NJ, US
DecisionSubstantially Equivalent, May 2, 2001
ReceivedJul 20, 2000
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K002186

DateFirm and productCodeLinked 510(k)
Jun 3, 2005Philips Ultrasound, Inc.
Philips HDI 4000 Ultrasound System Part numbers 9896 053 15031 (8500-0066-01), 9896 053 18811 (8500-0080-01), 9896 053 22011 (8500-0087-01)
Terminated
DPWNone listed

Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.