Company · US
Cordis US Corp
FDA 510(k) clearances and medical device recalls filed under this name, 2022 to 2024. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
22recalls (0 in 12 months)
18recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| NTE | Temporary Carotid Catheter For Embolic Capture | 14 |
| DQO | Catheter, Intravascular, Diagnostic | 3 |
| DQY | Catheter, Percutaneous | 2 |
| MGB | Device, Hemostasis, Vascular | 2 |
| NIO | Stent, Iliac | 2 |
| DYB | Introducer, Catheter | 1 |
| FGE | Stents, Drains And Dilators For The Biliary Ducts | 1 |
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jun 28, 2024 | K233637 | Cordis BRITECROSS Support Catheter Cordis US Corp | DQY |
| Nov 21, 2023 | K232573 | INFINITI Ambi Angiographic Catheter Cordis US Corp | DQO |
| Apr 24, 2023 | K230704 | RAIN Sheath Tibial Pedal Introducer Cordis US Corp | DYB |
| Aug 22, 2022 | K221832 | SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter Cordis US Corp | LIT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 3, 2025 | Cordis US Corp Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F, SterileEO, Rx Only Open, Classified |
NIO | None listed |
| Apr 3, 2025 | Cordis US Corp Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F, SterileEO, Rx Only Open, Classified |
NIO | None listed |
| Mar 13, 2025 | Cordis US Corp Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F.
Guiding catheter is intended for use for intravascular introduction of interventional/diagnostic devices into the coronary or Open, Classified |
DQY | K021593 |
| Jan 5, 2024 | Cordis US Corp MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites Open, Classified |
MGB | None listed |
| Jan 5, 2024 | Cordis US Corp MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial and femoral venous access sites. Open, Classified |
MGB | None listed |
| Nov 9, 2023 | Cordis US Corp Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac catheter Open, Classified |
DQO | K970854 |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RE Open, Classified |
NTE | K220654 |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RM Open, Classified |
NTE | K220654 |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RM Open, Classified |
NTE | K220654 |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RE Open, Classified |
NTE | K220654 |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RE Open, Classified |
NTE | K220654 |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RE Open, Classified |
NTE | K220654 |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RM Open, Classified |
NTE | K220654 |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REC Open, Classified |
NTE | K220654 |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MC Open, Classified |
NTE | K220654 |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMC Open, Classified |
NTE | K220654 |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMC Open, Classified |
NTE | K220654 |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMC Open, Classified |
NTE | K220654 |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMC Open, Classified |
NTE | K220654 |
| May 11, 2023 | Cordis US Corp ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMC Open, Classified |
NTE | K220654 |
| Dec 16, 2022 | Cordis US Corp Cordis Angiographic Catheter Extensions.
Used to transport fluid from the power injector to the catheter for injection into the patient. Open, Classified |
DQO | K970854 |
| May 20, 2022 | Cordis US Corp PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog numbers PG2990BPS, PG2990BPX, PG3990BPS, PG3990BPX. Open, Classified |
FGE | K033394 |