510(k) K220654 ยท NTE Temporary Carotid Catheter For Embolic Capture
ANGIOGUARD XP Emboli Capture Guidewire, ANGIOGUARD RX Emboli Capture Guidewire
| Applicant | Cordis Corporation, Miami Lakes FL, US |
| Decision | Substantially Equivalent, Apr 6, 2022 |
| Received | Mar 7, 2022 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K220654
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC Open, Classified |
NTE | None listed |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC Open, Classified |
NTE | None listed |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC Open, Classified |
NTE | None listed |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC Open, Classified |
NTE | None listed |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC Open, Classified |
NTE | None listed |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MC Open, Classified |
NTE | None listed |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC Open, Classified |
NTE | None listed |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM Open, Classified |
NTE | None listed |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RE Open, Classified |
NTE | None listed |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE Open, Classified |
NTE | None listed |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RE Open, Classified |
NTE | None listed |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM Open, Classified |
NTE | None listed |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM Open, Classified |
NTE | None listed |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE Open, Classified |
NTE | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.