ClearanceBrief
510(k) K220654 ยท NTE Temporary Carotid Catheter For Embolic Capture

ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire

ApplicantCordis Corporation, Miami Lakes FL, US
DecisionSubstantially Equivalent, Apr 6, 2022
ReceivedMar 7, 2022
TypeSpecial
FDA recordOpen on fda.gov

Recalls that name K220654

DateFirm and productCodeLinked 510(k)
May 11, 2023Cordis US Corp
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC
Open, Classified
NTENone listed
May 11, 2023Cordis US Corp
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC
Open, Classified
NTENone listed
May 11, 2023Cordis US Corp
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC
Open, Classified
NTENone listed
May 11, 2023Cordis US Corp
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC
Open, Classified
NTENone listed
May 11, 2023Cordis US Corp
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC
Open, Classified
NTENone listed
May 11, 2023Cordis US Corp
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MC
Open, Classified
NTENone listed
May 11, 2023Cordis US Corp
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC
Open, Classified
NTENone listed
May 11, 2023Cordis US Corp
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM
Open, Classified
NTENone listed
May 11, 2023Cordis US Corp
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RE
Open, Classified
NTENone listed
May 11, 2023Cordis US Corp
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE
Open, Classified
NTENone listed
May 11, 2023Cordis US Corp
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RE
Open, Classified
NTENone listed
May 11, 2023Cordis US Corp
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM
Open, Classified
NTENone listed
May 11, 2023Cordis US Corp
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM
Open, Classified
NTENone listed
May 11, 2023Cordis US Corp
ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE
Open, Classified
NTENone listed

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