ClearanceBrief
510(k) K022412 ยท KDJ Set, Administration, For Peritoneal Dialysis, Disposable

FRESENIUS CAPD STAY.SAFE DISPOSABLE ADMINISTRATION SETS WITH STAY.SAFE CONNECTOR

ApplicantFresenius Medical Care North America, Lexington MA, US
DecisionSubstantially Equivalent, Mar 5, 2003
ReceivedJul 24, 2002
TypeTraditional
FDA recordOpen on fda.gov

Recalls that name K022412

DateFirm and productCodeLinked 510(k)
Mar 26, 2024Fresenius Medical Care Holdings, Inc.
stay-safe /Safe Lock Catheter Ext. 12 in
Open, Classified
KDJNone listed
Mar 26, 2024Fresenius Medical Care Holdings, Inc.
stay-safe /Luer Lock Adapter 4 in
Open, Classified
KDJNone listed
Mar 26, 2024Fresenius Medical Care Holdings, Inc.
stay-safe /Luer Lock Catheter Ext. 12 in
Open, Classified
KDJNone listed
Mar 26, 2024Fresenius Medical Care Holdings, Inc.
stay-safe /Luer Lock Catheter Ext. 18 in
Open, Classified
KDJNone listed
Mar 26, 2024Fresenius Medical Care Holdings, Inc.
stay-safe /Luer Catheter Ext. 6 in
Open, Classified
KDJNone listed

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