FDA.reportPublic FDA data

Capiox® iCP Centrifugal Pump

Primary DI
50699753450979
Brand
Capiox® iCP Centrifugal Pump
Company
Terumo Cardiovascular Systems Corporation
Model
3CX*CP8J
Published
2022-06-17
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller Type

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KFMPump, Blood, Cardiopulmonary Bypass, Non-Roller TypeCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K200091000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K200091000Capiox iCP Centrifugal PumpTerumo Cardiovascular Systems Corporation2021-11-18KFM

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
50699753450979PackageGS18In Commercial Distribution
00699753450974PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
5069975345097950699753450979
00699753450974006997534509746997534509740699753450974

GMDN Terms#

Term, Definition table
TermDefinition
Cardiopulmonary bypass system centrifugal pumpA device intended to be connected to a drive unit (not included) to circulate blood through the extracorporeal circuit of a non-roller type cardiopulmonary bypass system, via a centrifugal force mechanism, for gas exchange and reinfusion; it may in addition be used in extracorporeal support systems for ventricular support/circulatory assistance. It includes flow channels and a rotor driven by the system’s drive unit. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
177655466
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00699753532069Cardiovascular Procedure Kit75411-042024-07-09
00699753532021Cardiovascular Procedure Kit74454-052024-07-08
00699753531932Cardiovascular Procedure Kit78044-012024-07-02
00699753531567Cardiovascular Procedure Kit72149-022024-05-29
00699753531574Cardiovascular Procedure Kit77742-012024-05-29
00699753517721Cardiovascular Procedure Kit75410-022022-10-19
00699753538177Cardiovascular Procedure Kit76754-012026-10-22
00699753538184Cardiovascular Procedure Kit788202026-10-22
00699753538191Cardiovascular Procedure KitCX-UK7722026-10-22
00699753538061Cardiovascular Procedure KitCX-CZ227X2026-10-09
00699753538078Cardiovascular Procedure KitCX-CZ2282026-10-09
00699753538085Cardiovascular Procedure KitCX-SP296X2026-10-09
00699753538092Cardiovascular Procedure KitCX-SP297X2026-10-09
00699753538108Cardiovascular Procedure Kit787582026-10-09
00699753538115Cardiovascular Procedure Kit788232026-10-09
00699753538122Cardiovascular Procedure Kit787472026-10-09
00699753538139Cardiovascular Procedure Kit787482026-10-09
00699753538146Cardiovascular Procedure Kit787442026-10-09
00699753538153Cardiovascular Procedure Kit787462026-10-09
00699753538160Cardiovascular Procedure Kit787452026-10-09

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
18051160300614Quantum Perfusion Centrifugal Blood Pump CP37SPECTRUM MEDICAL SRLKFM2026-05-21
00643169845114NAMEDTRONIC, INC.KFM2025-12-22
18051160302977Quantum Perfusion Centrifugal Blood Pump CP20NG with Integrated SensorsSPECTRUM MEDICAL SRLKFM2025-08-28
18051160302991Quantum Perfusion Centrifugal Blood Pump CP22NG with Integrated Sensors SPECTRUM MEDICAL SRLKFM2025-07-14
18051160302663Quantum Perfusion Centrifugal Blood Pump CP37 with Integrated SensorsSPECTRUM MEDICAL SRLKFM2024-01-12
08051160300846Quantum Perfusion Centrifugal Blood Pump CP20 with Integrated SensorsSPECTRUM MEDICAL SRLKFM2023-06-27
18051160302144Quantum Perfusion Centrifugal Blood Pump CP20SPECTRUM MEDICAL SRLKFM2023-06-27
05415067036414CentriMag™Thoratec CorporationKFM2023-05-17
05060434422132QuantumSPECTRUM MEDICAL LIMITEDKFM2022-10-25
05060434422149QuantumSPECTRUM MEDICAL LIMITEDKFM2022-10-25
00699753450967Capiox® iCP Centrifugal PumpTerumo Cardiovascular Systems CorporationKFM2022-06-17
00699753450974Capiox® iCP Centrifugal PumpTerumo Cardiovascular Systems CorporationKFM2022-06-17
50699753450962Capiox® iCP Centrifugal PumpTerumo Cardiovascular Systems CorporationKFM2022-06-17
08051160300624Quantum Perfusion Centrifugal Blood Pump CP22 with Integrated SensorsSPECTRUM MEDICAL SRLKFM2021-11-15
04058863076355HLS SetMaquet Cardiopulmonary AGKFM2021-07-29
04058863078861HLS SetMaquet Cardiopulmonary AGKFM2021-07-29
04058863080383HLS SetMaquet Cardiopulmonary AGKFM2021-07-29
00814321020438FloPumpMovair, Inc.KFM2021-03-12
00814321020445FloPumpMovair, Inc.KFM2021-03-12
00860001797947Abiomed Breethe OXY-1 SystemBreethe, Inc.KFM2020-11-30
00763000134532Affinity™MEDTRONIC, INC.KFM2020-10-20
00763000134556Affinity™MEDTRONIC, INC.KFM2020-10-20
00763000134563Affinity™MEDTRONIC, INC.KFM2020-10-20
20763000134536Affinity™MEDTRONIC, INC.KFM2020-10-20
20763000134550Affinity™MEDTRONIC, INC.KFM2020-10-20
20763000134567Affinity™MEDTRONIC, INC.KFM2020-10-20
00814112020692TandemLife LifeSPARCCARDIACASSIST, INC.KFM2020-06-01
00814112020708TandemLife LifeSPARCCARDIACASSIST, INC.KFM2020-06-01
00763000301323Affinity™ CPMEDTRONIC, INC.KFM2020-05-31
00814112020609LifeSPARCCARDIACASSIST, INC.KFM2020-05-29