ClearanceBrief
Panels › Cardiovascular › Product code KFM · Class 2

Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type

Regulation 870.4360

0510(k)s in 12 months (84 all time)
0recalls in 12 months (40 all time)
39recalls that name a 510(k)
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Top companies in KFM

DateFirm and productCodeLinked 510(k)
Mar 13, 2025Spectrum Medical Inc
Brand Name: Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated Sensors Product Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type Model/Catalog Number: CP22V-VT Software Version: N/
Open, Classified
KFMK201320
Feb 2, 2024Maquet Medical Systems USA
BO-RF-32-USA RotaFlow Centrifugal Pump with SOFTLINE Coating, Product Code 701047553. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
Open, Classified
KFMK090515
Feb 2, 2024Maquet Medical Systems USA
BEQ-RF-32-USA RotaFlow Centrifugal Pump with BIOLINE Coating, Product Code 701047554. For use with an extracorporeal cardiovascular or cardiopulmonary bypass circuit.
Open, Classified
KFMK080470
Aug 25, 2023Cardiac Assist, Inc
LifeSPARC Pump (part number 5800-0000) contained within TandemLife LifeSPARC Priming Tray part number: 5800-1000. Note: The 5800-1000 model number is an individually packaged component contained wit
Open, Classified
KFMK183623
Aug 12, 2021QURA S.R.L.
Spectrum Medical Quantum Standard heat exchanger
Terminated
KFMNone listed
Aug 7, 2020Maquet Cardiovascular Us Sales, Llc
Maquet/Getinge Rotaflow System Console US (115 V / 60 Hz) - Product Usage: Instructions for Use - Centrifugal Pump System is a device that uses a method other than revolving rollers to pump the blood
Terminated
KFMK991864
Mar 6, 2020Cardiac Assist, Inc
TandemHeart pump is assembled into kits: TandemLife Kit Product: 5740-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver a
Terminated
KFMK110493
Mar 6, 2020Cardiac Assist, Inc
TandemHeart pump is assembled into kits: TandemLung Kit - DL31, Product: 5730-3118 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally de
Terminated
KFMK110493
Mar 6, 2020Cardiac Assist, Inc
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL31 RD, Product: 5720-3631 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally
Terminated
KFMK110493
Mar 6, 2020Cardiac Assist, Inc
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL3, Product: 5720-3118 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally del
Terminated
KFMK110493
Mar 6, 2020Cardiac Assist, Inc
TandemHeart pump is assembled into kits: ProtekDuo Kit - DL29, Product: 5720-2916 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally del
Terminated
KFMK110493
Mar 6, 2020Cardiac Assist, Inc
TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A17, Product: 5710-6217 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to local
Terminated
KFMK110493
Mar 6, 2020Cardiac Assist, Inc
TandemHeart pump is assembled into kits: TandemHeart Kit - TS62/A15, Product: 5710-6215 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locall
Terminated
KFMK110493
Mar 6, 2020Cardiac Assist, Inc
TandemHeart Pump Kit, Product: 5120-0000 - Product Usage: provides temporary extracorporeal circulatory system support with the unique ability to locally deliver an anticoagulant through the infusion
Terminated
KFMK110493
Dec 3, 2019Maquet Cardiovascular Us Sales, Llc
Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console.
Terminated
KFMK991864
Oct 30, 2019Thoratec Switzerland GMBH
CentriMag Acute Circulatory Support System Motor, U.S. Model 102956 and OUS Model 201-10002, a component of the CentriMag Extracorporeal Blood Pumping System.
Terminated
KFMK020271
Jun 24, 2019OriGen Biomedical, Inc.
3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only
Terminated
KFMK170029
Oct 12, 2018Thoratec Switzerland GMBH
Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System.
Terminated
KFMK020271
K083340 +3
Feb 22, 2017Terumo Cardiovascular Systems Corporation
The Sarns Centrifugal Pump is a single use device sterilized by ethylene oxide gas. The device is sold single sterile in cartons of 8 units, or may be provided in bulk, non-sterile to another Teru
Terminated
KFMK112229
Feb 23, 2016Maquet Cardiovascular Us Sales, Llc
Custom Tubing Packs Custom tubing pack for oxygenators
Terminated
KFMK080592
Feb 23, 2016Maquet Cardiovascular Us Sales, Llc
Rotaflow Centrifugal Pump Custom tubing packs for the oxygenator
Terminated
KFMK080470
Jul 11, 2014Terumo Cardiovascular Systems Corporation
Cardiovascular Procedure Kit containing Disposable Centrifugal Pumphead with or without X-Coating, sterile single use. Catalog numbers 73431, 73813-03, 74277, 72481-01, 72427, 70947-03, 74570-01, 7
Terminated
KFMK112229
Jul 11, 2014Terumo Cardiovascular Systems Corporation
Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
Terminated
KFMK112229
Jul 11, 2014Terumo Cardiovascular Systems Corporation
Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device. For use in cardiopulmonary bypass procedures.
Terminated
KFMK112229
Oct 11, 2012Terumo Cardiovascular Systems Corporation
Battery, 220V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Terminated
KFMK882758
Oct 11, 2012Terumo Cardiovascular Systems Corporation
Battery, 100/115V (Includes charger and connecting cable) The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Terminated
KFMK882758
Oct 11, 2012Terumo Cardiovascular Systems Corporation
Sarns Centrifugal System Control module System 9000 The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Terminated
KFMK882758
Oct 11, 2012Terumo Cardiovascular Systems Corporation
Sarns Centrifugal System Control module, 220/240V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Terminated
KFMK882758
Oct 11, 2012Terumo Cardiovascular Systems Corporation
Sarns Centrifugal System Control module, 100/115V The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only.
Terminated
KFMK882758
Jan 14, 2012Sorin Group USA, Inc.
SYNERGY Perfusion Tubing Systems US Denver PHISIO, Sorin Group USA, Tubing set heart-lung bypass, Sterile EO, manufactured by: Sorin Group Italia, Via Statale 12 Nord, 86, 41037 Mirandola (MO) Italy.
Terminated
KFMK032040
Sep 28, 2010Terumo Cardiovascular Corporation
Sarns Centrifugal Pump with X-Coating, packaged within custom ordered Cardiovascular Procedure Kits, P/N 3ZZ164275X, 3ZZ164275, CEOT028, CEOT032; and as single sterile units with product codes CV-1642
Terminated
KFMK020998
Sep 7, 2010Abiomed, Inc.
Impella 5.0 Circulatory Support System Catalog number: 004840 The Impella 5.0 System is intended for circulatory support using an extracorporeal bypass control unit, for periods up to 6 hours
Terminated
KFMK083111
Dec 17, 2009Terumo Cardiovascular Systems Corporation
Sarns Centrifugal Pump (without X-coating), catalog 164275, packaged in 8 piece shelf boxes, and convenience kits with single pump units. Indicated as extracorporeal blood pumps for use in cardiopulm
Terminated
KFMK915363
Dec 17, 2009Terumo Cardiovascular Systems Corporation
Sarns Centrifugal Pump (with X-coating), catalog 164275X, packaged in 8 piece shelf boxes, and convenience kits with single pump units. Indicated as extracorporeal blood pumps for use in cardiopulmon
Terminated
KFMK020998
Nov 13, 2009Sorin Group USA, Inc.
Revolution Blood Pump with PC Coating, "revOlution Centrifugal pump Catalog# 050300700***Rx ONLY***SORIN GROUP ITALIA via Statale 12 Nord, 86 41037 MIRANDOLA (MO) (Italy) Distributed in the U.S. by: S
Terminated
KFMK030462
Nov 13, 2009Sorin Group USA, Inc.
Revolution Blood Pump, "revOlution Centrifugal pump Catalog# 050300000***Rx ONLY***SORIN GROUP ITALIA via Statale 12 Nord, 86 41037 MIRANDOLA (MO) (Italy) Distributed in the U.S. by: Sorin Group USA,
Terminated
KFMK011835
Jul 23, 2008Levitronix, Llc
Levitronix CentriMag Back-Up Console Article Number: 201-30200; extracorporeal blood circulation system.
Terminated
KFMK051209
Jul 23, 2008Levitronix, Llc
Levitronix CentriMag Primary System, Article Number: 201-30100; extracorporeal blood circulation system.
Terminated
KFMK020271
Mar 14, 2007Terumo Cardiovascular Systems Corp
Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System; Catalog No. 164268.
Terminated
KFMK882758
Nov 16, 2005Terumo Cardiovascular Systems Corp
Terumo/Capiox Cardiovascular Kit containing the CAPIOX Disposable Centrifugal Pump The centrifugal pump is designated as TCVS Product Code 1ZZ*SP45A. The devices are assembled with PVC tubing and oth
Terminated
KFMK962981

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