Panels › Cardiovascular › Product code DXC · Class 2
Clamp, Vascular
Regulation 870.4450
6510(k)s in 12 months (205 all time)
0recalls in 12 months (26 all time)
26recalls that name a 510(k)
Top companies in DXC
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Sep 26, 2025 | North American Rescue LLC. JUNCTIONAL EMERGENCY TREATMENT TOOL (JETT), REF: 30-0088, a component inside kits:
KIT, TCCC Training- Complete (Modules 1-3), REF: 85-0550;
KIT, TCCC MODULE ONE - SKILLS, REF: 85-0519;
KIT, MULTI M Open, Classified |
DXC | K123194 |
| Sep 18, 2025 | Maquet Cardiovascular, LLC Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder. Open, Classified |
DXC | K130382 |
| Sep 18, 2025 | Maquet Cardiovascular, LLC Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder. Open, Classified |
DXC | K130382 |
| Sep 18, 2025 | Maquet Cardiovascular, LLC Heartstring III Proximal Seal System. Intravascular anastomosis occluder. Open, Classified |
DXC | K130382 |
| Apr 12, 2024 | Baxter Healthcare Corporation Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specia Open, Classified |
DXC | K130896 |
| Apr 12, 2024 | Baxter Healthcare Corporation Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specia Open, Classified |
DXC | K981624 |
| Apr 12, 2024 | Baxter Healthcare Corporation Surgical Tools and Cardiovascular Specialty marketing brochures, Reference numbers: US-AS18-210002 Surgical Tools Brochure 2021, US-AS18-210004 Surgical Tools Website v1, and US-AS46-230002 CV Specia Open, Classified |
DXC | K942812 |
| Jan 5, 2024 | Baxter Healthcare Corporation Baxter Flo-Thru Intraluminal Shunt, Product Codes:
a) Product Code FT12100, 1.00 GLOBAL;
b) Product Code FT12125, 1.25 GLOBAL;
c) Product Code FT12150, 1.50 GLOBAL;
d) Product Code FT12175, 1.75 G Open, Classified |
DXC | K981624 |
| Jan 5, 2024 | Baxter Healthcare Corporation Baxter Flo-Rester, Disposable internal vessel occluder, distributed in the following sizes:
a) Product Code 50100: 12MM, 1.00 MM GLOBAL;
b) Product Code 50150: 12MM, 1.50 MM GLOBAL;
c) Product Cod Open, Classified |
DXC | K883696 |
| Apr 29, 2022 | Baxter Healthcare Corporation Flo-Thru Intraluminal Shunt. Used in coronary artery or peripheral vascular
procedures. Used to shunt blood at the anastomosis to provide a temporary blood-free operative field for suturing while allo Terminated |
DXC | K981624 |
| Mar 11, 2020 | Merit Medical Systems, Inc. PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT Terminated |
DXC | K180723 |
| Aug 7, 2019 | Integra LifeSciences Corp. Integra Jarit GEMINI CLAMP 9 1/4 inch - used in vascular and cardiothoracic procedures used for clamping and occluding vessels.
Cat. #140-332 Terminated |
DXC | K102048 |
| Jun 11, 2019 | Edwards Lifesciences, LLC IntraClude Intra-Aortic Occlusion Device, REF: ICF100, 10.5 Fr (3.5 mm) X 39.4" (100 cm), Rx Only, Sterile EO
The IntraClude intra-aortic occlusion device is indicated for use in patients undergoing Terminated |
DXC | K113182 K132175 +1 |
| Jan 16, 2019 | Edwards Lifesciences, LLC Edwards Lifesciences(R) IntraClude(TM) Intra-Aortic Occlusion Device
is a 10.5 Fr (3.5mm), triple lumen, 100cm long catheter with an elastomeric balloon near its distal tip designed to occlude the a Open, Classified |
DXC | K163693 |
| Mar 30, 2018 | Edwards Lifesciences, LLC Edwards Lifesciences' IntraClude Intra-Aortic Occlusion Device. Packaged in a sterile barrier system. Model Number: ICF100.
Designed to occlude the ascending aorta. Terminated |
DXC | K163693 |
| Apr 10, 2017 | Merit Medical Systems, Inc. The PreludeSYNC Radial Compression Device is a sterile, single use disposable device used to assist in gaining and maintaining hemostasis of the radial and ulnar artery following catheterization proce Terminated |
DXC | K162988 |
| Jun 11, 2015 | Edwards Lifesciences, LLC Edwards Lifesciences IntraClude Intra-Aortic Occlusion Device, model number ICF100, 10.5 Fr (3.5 mm) x 39.4" (100 cm) ThruPort System. Packaged sterile and non-pyrogenic in a sealed, peel-type pouch
Terminated |
DXC | K132175 |
| Dec 16, 2014 | Sam Medical Products SAM Junctional Tourniquet (SJT) Auxiliary, Model SJT 102 and SJT 112.
The SJT models specific intended uses are to control difficult bleeds in the inguinal area and to immobilize a pelvic fracture. Terminated |
DXC | K123694 K131561 |
| Aug 11, 2011 | Applied Medical Resources Corp Surgical Clamp Inserts, Model#G-8655, 86MM Insert Fibra/Fibra 15/Bx
Surgical Clamps and inserts are indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery. Th Terminated |
DXC | K883790 |
| Aug 11, 2011 | Applied Medical Resources Corp Surgical Clamp Inserts, Model#G-8650, 86MM Insert Soft/Fibra 15/Bx
Surgical Clamps and inserts are indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery. The Terminated |
DXC | K883790 |
| Aug 11, 2011 | Applied Medical Resources Corp Surgical Clamp Inserts, Model#G-8600, 86MM Insert Soft/Traction, 15/Bx
Surgical Clamps and inserts are indicated for surgical clamping during cardiovascular, peripheral vascular, and general surgery. Terminated |
DXC | K883790 |
| Feb 1, 2011 | Maquet Cardiovascular, LLC Maquet Heartstring II Proximal Seal System (HS-1045) manufactured by Maquet Cardiovascular, Wayne, NJ
Intended use: medical device for use by cardiac surgeons during CABG procedures to maintain hemos Terminated |
DXC | K022880 |
| Nov 6, 2009 | Edwards Lifesciences Research Medical, Inc. EndoClamp aortic catheter label reading in part: "CARDIOVATIONS EndoClamp aortic catheter 65 cm,STERILE R, REF EC65, Edwards
Lifesciences LLC Irvine, CA 92614-5686" The device is a 10.5Fr wirewound, t Terminated |
DXC | K955132 K962510 +2 |
| Nov 6, 2009 | Edwards Lifesciences Research Medical, Inc. EndoClamp aortic catheter. Label reading in part: "***CARDIOVATIONS EndoClamp aortic catheter 100 cm, REF EC1001, Sterile EO, Sterile
R, Edwards Lifesciences LLC Irvine, CA***". The device is a 10.5Fr Terminated |
DXC | K955132 K962510 +1 |
| Jan 5, 2009 | Edwards Lifesciences Research Medical, Inc. CardioVations Ethicon, a Johnson and Johnson company, EndoClamp aortic catheter 100 cm, REF EC1001, Sterile R, individually packaged, Heartport, Inc., Somerville, NJ 08876. This product is indicated Terminated |
DXC | K964161 |
| Jan 5, 2009 | Edwards Lifesciences Research Medical, Inc. Edwards Lifesciences CardioVations, EndoClamp aortic catheter 100 cm, REF EC1001, Sterile R, individually packaged, Edwards Lifesciences LLC, Irvine, CA 92614. This product is indicated for use in p Terminated |
DXC | K964161 |
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