ClearanceBrief
510(k) K003598 ยท DSP System, Balloon, Intra-Aortic And Control

DATASCOPE PROFILE 8FR. ALT B IAB, 34CC, DATASCOPE PROFILE 8FR. ALT B IAB, 40CC, MODEL 0684-000319, 0684-00-0320

ApplicantDatascope Corp., Fairfield NJ, US
DecisionSubstantially Equivalent, Dec 21, 2000
ReceivedNov 21, 2000
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K003598

No recall in the FDA data names this 510(k).

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