ClearanceBrief
510(k) K121694 ยท DQO Catheter, Intravascular, Diagnostic

IMAGER II ANGIOGRAPHIC CATHETER

ApplicantBoston Scientific Corp, Maple Grove MN, US
DecisionSubstantially Equivalent, Sep 14, 2012
ReceivedJun 7, 2012
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K121694

DateFirm and productCodeLinked 510(k)
Sep 23, 2026Boston Scientific Corporation
Imager II Angiographic Catheters M001314001 IMAGER II/5/ST/65/038 BX5; M001314011 IMAGER II/5/ST/100/038 BX5; M001314021 IMAGER II/5/ST/65/035 BX 5; M001314031 IMAGER II/5/ST/100/035 BX 5; M00131
Open, Classified		 DQONone listed
Mar 25, 2020Boston Scientific Corporation
Imager II 5F Angiographic Catheters, 5 units per package.
Open, Classified		 DQONone listed
Jun 27, 2017Boston Scientific Corporation
Boston Scientific Imager II Angiographic Catheter, a pathway for delivering contrast media to selected sites in the vascular system. M001314141 (5-pack outer package UPN), M001314140, single unit, inn
Terminated		 DQONone listed
Mar 23, 2017Boston Scientific Corporation
Boston Scientific Imager II Angiographic Catheter, M001316581 (5-pack outer package UPN), M001316580, single unit, inner package UPN)
Terminated		 DQONone listed

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