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Panels › Cardiovascular › Product code KRI · Class 1

Accessory Equipment, Cardiopulmonary Bypass

Regulation 870.4200

0510(k)s in 12 months (42 all time)
0recalls in 12 months (8 all time)
2recalls that name a 510(k)
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Top companies in KRI

DateFirm and productCodeLinked 510(k)
Jul 29, 2025Maquet Cardiopulmonary Gmbh
Sprinter Cart/Sprinter Cart XL Infusion Pole. Component used to hold 2 x 2 kg infusion bags.
Open, Classified
KRINone listed
Jun 18, 2020Maquet Cardiovascular Us Sales, Llc
Holder HKHZ 19 for use with Quadrox-i and Quadrox-iD Neonatal / Pediatric Oxygenators, Model Number: 701047495 - Product Usage: The Holder HKHZ 19 is an accessory to QUADROX i and QUADROX iD Neonatal
Terminated
KRINone listed
Apr 4, 2018Maquet Cardiopulmonary Ag
CARDIOHELP Gas Bottle Holder HKH 8880, Product Code/Part Number 70105.0901 Product Usage: The Cardiohelp Gas Bottle (or Cylinder) Holder HKH 8880 is an accessory for the CARDIOHELP System and require
Terminated
KRIK102726
Oct 31, 2014Terumo Cardiovascular Systems Corp
Terumo Custom Integrated Cardioplegia Delivery Set-LINE FOR 15501/16015/5852 Item Number: 16110 Product Usage: This is a replacement line to multiple Cardioplegia Delivery Sets - and includes th
Terminated
KRIK810079
Oct 16, 2012Terumo Cardiovascular Systems Corporation
Terumo Backplate Replacement CXFVR 1500 Holder The Flexible venous Reservoir is mounted on the Backplate/Holder and secures the flexible reservoir by strategically placed mounting arms. Additionally,
Terminated
KRINone listed
Sep 9, 2011Terumo Cardiovascular Systems Corporation
Terumo Sarns Level Sensor II Pads. Terumo Cardiovascular Systems Corporation. Used to attach level sensors to the sides of the venous reservoir.
Terminated
KRINone listed
Feb 26, 2010Medtronic Inc
ONE SOURCE PACK, Model TK2S24, EE2S048 (OUS), Manufacturer: Medtronic, Inc., Minneapolis, MN 55432-5604.
Terminated
KRINone listed
Feb 26, 2010Medtronic Inc
IDEAL MAXPAC TOTAL SYSTEM (USA) , Sterile and Nonpyrogenic, ETO or Gamma Sterilized, Medtronic Perfusion Systems, Model TS9453R29, TS9453R30, TS1470R1, TS1442R1, TS9800R32, TS8299R4.
Terminated
KRINone listed

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