ClearanceBrief
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)
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Top companies in DXC

DateFirm and productCodeLinked 510(k)
Sep 26, 2025North 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
DXCK123194
Sep 18, 2025Maquet Cardiovascular, LLC
Heartstring III Proximal Seal System, 4.3 MM. Intravascular anastomosis occluder.
Open, Classified
DXCK130382
Sep 18, 2025Maquet Cardiovascular, LLC
Heartstring III Proximal Seal System, 3.8 MM. Intravascular anastomosis occluder.
Open, Classified
DXCK130382
Sep 18, 2025Maquet Cardiovascular, LLC
Heartstring III Proximal Seal System. Intravascular anastomosis occluder.
Open, Classified
DXCK130382
Apr 12, 2024Baxter 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
DXCK130896
Apr 12, 2024Baxter 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
DXCK981624
Apr 12, 2024Baxter 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
DXCK942812
Jan 5, 2024Baxter 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
DXCK981624
Jan 5, 2024Baxter 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
DXCK883696
Apr 29, 2022Baxter 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
DXCK981624
Mar 11, 2020Merit Medical Systems, Inc.
PreludeSYNC DISTAL Radial Compression Devices, SDRB-REG-LT, SDRB-REG-RT
Terminated
DXCK180723
Aug 7, 2019Integra 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
DXCK102048
Jun 11, 2019Edwards 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
DXCK113182
K132175 +1
Jan 16, 2019Edwards 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
DXCK163693
Mar 30, 2018Edwards 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
DXCK163693
Apr 10, 2017Merit 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
DXCK162988
Jun 11, 2015Edwards 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
DXCK132175
Dec 16, 2014Sam 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
DXCK123694
K131561
Aug 11, 2011Applied 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
DXCK883790
Aug 11, 2011Applied 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
DXCK883790
Aug 11, 2011Applied 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
DXCK883790
Feb 1, 2011Maquet 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
DXCK022880
Nov 6, 2009Edwards 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
DXCK955132
K962510 +2
Nov 6, 2009Edwards 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
DXCK955132
K962510 +1
Jan 5, 2009Edwards 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
DXCK964161
Jan 5, 2009Edwards 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
DXCK964161

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