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)
Top companies in KFM
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 13, 2025 | Spectrum 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 |
KFM | K201320 |
| Feb 2, 2024 | Maquet 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 |
KFM | K090515 |
| Feb 2, 2024 | Maquet 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 |
KFM | K080470 |
| Aug 25, 2023 | Cardiac 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 |
KFM | K183623 |
| Aug 12, 2021 | QURA S.R.L. Spectrum Medical Quantum Standard heat exchanger Terminated |
KFM | None listed |
| Aug 7, 2020 | Maquet 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 |
KFM | K991864 |
| Mar 6, 2020 | Cardiac 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 |
KFM | K110493 |
| Mar 6, 2020 | Cardiac 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 |
KFM | K110493 |
| Mar 6, 2020 | Cardiac 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 |
KFM | K110493 |
| Mar 6, 2020 | Cardiac 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 |
KFM | K110493 |
| Mar 6, 2020 | Cardiac 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 |
KFM | K110493 |
| Mar 6, 2020 | Cardiac 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 |
KFM | K110493 |
| Mar 6, 2020 | Cardiac 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 |
KFM | K110493 |
| Mar 6, 2020 | Cardiac 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 |
KFM | K110493 |
| Dec 3, 2019 | Maquet Cardiovascular Us Sales, Llc Maquet Cardiopulmonary (MCP)/Getinge ROTAFLOW Drive, Model Number 701022161. The device is a component of the ROTAFLOW System Console. Terminated |
KFM | K991864 |
| Oct 30, 2019 | Thoratec 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 |
KFM | K020271 |
| Jun 24, 2019 | OriGen Biomedical, Inc. 3/8" FloPump, 32mL, (Sterile), REF 6400S, UDI: (01) 081432102013 1, Sterile EO, Rx Only Terminated |
KFM | K170029 |
| Oct 12, 2018 | Thoratec Switzerland GMBH Thoratec CentriMag Motor, Model: 102956, a component of the Thoratec CentriMag Blood Pumping System and PediMag Blood Pumping System. Terminated |
KFM | K020271 K083340 +3 |
| Feb 22, 2017 | Terumo 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 |
KFM | K112229 |
| Feb 23, 2016 | Maquet Cardiovascular Us Sales, Llc Custom Tubing Packs
Custom tubing pack for oxygenators Terminated |
KFM | K080592 |
| Feb 23, 2016 | Maquet Cardiovascular Us Sales, Llc Rotaflow Centrifugal Pump
Custom tubing packs for the oxygenator Terminated |
KFM | K080470 |
| Jul 11, 2014 | Terumo 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 |
KFM | K112229 |
| Jul 11, 2014 | Terumo Cardiovascular Systems Corporation Sarns Disposable Centrifugal Pump with X-Coating, 164275X, is a sterile, single use device.
For use in cardiopulmonary bypass procedures. Terminated |
KFM | K112229 |
| Jul 11, 2014 | Terumo Cardiovascular Systems Corporation Sarns Disposable Centrifugal Pump without X-Coating,164275, is a sterile, single use device.
For use in cardiopulmonary bypass procedures. Terminated |
KFM | K112229 |
| Oct 11, 2012 | Terumo Cardiovascular Systems Corporation Battery, 220V (Includes charger and connecting cable)
The Sarns" Centrifugal System is indicated for use in cardiopulmonary bypass procedures only. Terminated |
KFM | K882758 |
| Oct 11, 2012 | Terumo 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 |
KFM | K882758 |
| Oct 11, 2012 | Terumo Cardiovascular Systems Corporation Sarns Centrifugal System Control module System 9000
The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only. Terminated |
KFM | K882758 |
| Oct 11, 2012 | Terumo Cardiovascular Systems Corporation Sarns Centrifugal System Control module, 220/240V
The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only. Terminated |
KFM | K882758 |
| Oct 11, 2012 | Terumo Cardiovascular Systems Corporation Sarns Centrifugal System Control module, 100/115V
The Sarns Centrifugal System is indicated for use in cardiopulmonary bypass procedures only. Terminated |
KFM | K882758 |
| Jan 14, 2012 | Sorin 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 |
KFM | K032040 |
| Sep 28, 2010 | Terumo 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 |
KFM | K020998 |
| Sep 7, 2010 | Abiomed, 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 |
KFM | K083111 |
| Dec 17, 2009 | Terumo 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 |
KFM | K915363 |
| Dec 17, 2009 | Terumo 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 |
KFM | K020998 |
| Nov 13, 2009 | Sorin 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 |
KFM | K030462 |
| Nov 13, 2009 | Sorin 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 |
KFM | K011835 |
| Jul 23, 2008 | Levitronix, Llc Levitronix CentriMag Back-Up Console
Article Number: 201-30200; extracorporeal blood circulation system. Terminated |
KFM | K051209 |
| Jul 23, 2008 | Levitronix, Llc Levitronix CentriMag Primary System,
Article Number: 201-30100; extracorporeal blood circulation system. Terminated |
KFM | K020271 |
| Mar 14, 2007 | Terumo Cardiovascular Systems Corp Manual Drive Unit for Sarns (Terumo) Centrifugal Perfusion System; Catalog No. 164268. Terminated |
KFM | K882758 |
| Nov 16, 2005 | Terumo 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 |
KFM | K962981 |
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