ClearanceBrief
510(k) K111117 ยท MSD Catheter, Hemodialysis, Implanted

CANNON II PLUS CHRONIC HEMODIALYSIS CATHETER, EDGE CHRONIC HEMODIALYSIS CATHETER, NEXTSTEP(R) RETROGRADE CHRONIC...

ApplicantTeleflexmedical, Inc., Reading PA, US
DecisionUnknown, Jun 30, 2011
ReceivedApr 21, 2011
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K111117

DateFirm and productCodeLinked 510(k)
May 13, 2026ARROW INTERNATIONAL, LLC
Arrow Edge Hemodialysis Catheterization Product, REF: CS-15242-I, CS-15282-I, CS-15322-I
Open, Classified
MSDNone listed
May 13, 2026ARROW INTERNATIONAL, LLC
Cannon II Plus Hemodialysis Catheter, REF: CS-15242-VSP, CS-15282-VSP, CS-15322-VSP, CS-15362-VSP, CS-15552-VSP, CSD-15242-SP, CSD-15282-SP; Cannon II Plus Hemodialysis Catheter with Arrow Simplicity
Open, Classified
MSDNone listed
May 13, 2026ARROW INTERNATIONAL, LLC
NextStep Antegrade Chronic Hemodialysis Catheter, REF: AC-15192-SFX, AC-15232-SFX, CS-15192-SFX, CS-15232-SFX, CS-15272-SFX, CS-15312-SFX, CS-15422-SFX, CS-15502-SFX; NextStep Antegrade Hemodialysi
Open, Classified
MSDNone listed
Jan 22, 2015Arrow International Inc
The Arrow Edge Hemodialysis Catheterization Set Long-Term Access and NextStep Antegrade Hemodialysis Catheterization Set, Long-Term Access, part numbers: AC-15192-SFX, AC-15232-SFX, AC-15272-SFX, AC-1
Terminated
MSDNone listed

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