Cordis US Corp
Medical device manufacturer in Miami Lakes, FL.
4510(k) clearances
8PMA approvals
22recalls
Device types
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K233637 | Cordis BRITECROSS Support CatheterDQY · Traditional | 06/28/2024SE |
| K232573 | INFINITI Ambi Angiographic CatheterDQO · Traditional | 11/21/2023SE |
| K230704 | RAIN Sheath Tibial Pedal IntroducerDYB · Traditional | 04/24/2023SE |
| K221832 | SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation CatheterLIT · Traditional | 08/22/2022SE |
PMA approvals
- P220004 PALMAZ MULLINS XD Pulmonary Stent · 07/21/2023 · 2 supplements
- P150002 Incraft(R) Aaa Stent Graft System · 11/27/2018 · 11 supplements
- P120002 Sma RT Control and Smart Vascular Stent Systems · 11/07/2012 · 32 supplements
- P100013 Cordis Exoseal Vascular Closure Device · 05/19/2011 · 32 supplements
- P030047 Cordis Precise Nitinol Stent System · 09/22/2006 · 51 supplements
- P040044 Matrix Vascular Closure System (VSG) · 08/17/2005 · 107 supplements
- P020036 S.M.A.R.T. and S.M.A.R.T. Control Nitinol Stent System · 08/12/2003 · 56 supplements
- P890017 Palmaz Balloon Expandable Stent · 09/27/1991 · 18 supplements
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1511-2025 Class II | Cordis, REF: C09060ML, Smart Control Vascular Stent System ILIAC, 9mm X 60mm 6F…product mix-up; Vascular stent labeled as one size but contains a different size. | 03/04/2025Open, Classified |
| Z-1510-2025 Class II | Cordis, REF C10040ML, Smart Control Vascular Stent System ILIAC, 10mm X 40mm 6F…product mix-up; Vascular stent labeled as one size but contains a different size. | 03/04/2025Open, Classified |
| Z-1330-2025 Class II | Vista Brite Tip, Judkins Right 4, REF SM7504, JR3 VBT (Special) 110 cm 6F. Guiding…Catheter manufactured at the incorrect length. | 02/07/2025Open, Classified |
| Z-0675-2024 Class II | MYNXGRIP 6F/7F, REF MX6721, Vascular Closure Device (VCD). Used to seal femoral arterial…Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two… | 11/28/2023Open, Classified |
| Z-0674-2024 Class II | MYNXGRIP 5F, REF MX5021, Vascular Closure Device (VCD). Used to seal femoral arterial…Cordis became aware that the label for the carton box containing 10 units is incorrect for some boxes of two… | 11/28/2023Open, Classified |
| Z-0286-2024 Class I | Cordis ANGIOGRAPHIC CATHETERIZATION SETS, INFINITI THRULEMEN, 5F, REF CO0208, cardiac…Non-sterile product labeled as sterile was distributed. | 09/26/2023Open, Classified |
| Z-1496-2023 Class I | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814REThere is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which… | 03/24/2023Open, Classified |
| Z-1495-2023 Class I | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMThere is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which… | 03/24/2023Open, Classified |
| Z-1494-2023 Class I | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMThere is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which… | 03/24/2023Open, Classified |
| Z-1493-2023 Class I | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814REThere is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which… | 03/24/2023Open, Classified |
| Z-1492-2023 Class I | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814REThere is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which… | 03/24/2023Open, Classified |
| Z-1491-2023 Class I | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814REThere is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which… | 03/24/2023Open, Classified |
| Z-1490-2023 Class I | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMThere is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which… | 03/24/2023Open, Classified |
| Z-1489-2023 Class I | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RECThere is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which… | 03/24/2023Open, Classified |
| Z-1488-2023 Class I | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 603014MCThere is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which… | 03/24/2023Open, Classified |
| Z-1487-2023 Class I | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 801814RMCThere is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which… | 03/24/2023Open, Classified |
| Z-1486-2023 Class I | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 701814RMCThere is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which… | 03/24/2023Open, Classified |
| Z-1485-2023 Class I | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 601814RMCThere is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which… | 03/24/2023Open, Classified |
| Z-1484-2023 Class I | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 501814RMCThere is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which… | 03/24/2023Open, Classified |
| Z-1483-2023 Class I | ANGIOGUARD RX / XP Emboli Capture Guidewire System, REF 401814RMCThere is a potential for separation of the ANGIOGUARD RX / XP delivery system and capture sheath which… | 03/24/2023Open, Classified |
| Z-0720-2023 Class II | Cordis Angiographic Catheter Extensions. Used to transport fluid from the power injector…There is a potential for separation at the male connector. | 11/07/2022Open, Classified |
| Z-1363-2022 Class II | PALMAZ GENESIS Transhepatic Biliary Stent on OPTA PRO .035" Delivery System, Catalog…Potential for stent dislodgement and associated failures related to two specific sizes of the device. | 05/20/2022Open, Classified |