FDA.reportPublic FDA data

PiCCO catheter

Primary DI
27325710017108
Brand
PiCCO catheter
Company
Maquet Critical Care AB
Model
PV2014L22
Catalog number
6885047
Published
2026-03-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KRBProbe, Thermodilution

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRBProbe, ThermodilutionCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K171620000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K171620000PiCCO CatheterPulsion Medical Systems SE2018-02-21KRB

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
27325710017108PrimaryGS10
07325710017104Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2732571001710827325710017108
07325710017104073257100171047325710017104

GMDN Terms#

Term, Definition table
TermDefinition
Thermal dilution peripheral artery catheterA short, thin, flexible tube intended for short-term (<= 30 days) percutaneous placement into a peripheral artery (excluding pulmonary artery) during measurement/monitoring of haematological parameters (e.g., arterial pressure, cardiac output/index) using thermal dilution techniques. It is designed to be used as the downstream sensor during thermal dilution, whereby it is intended to be used in conjunction with a central venous catheter (intended for upstream solution introduction) and an external monitor. It includes an electronic thermistor and may include devices dedicated to introduction/function. This is a single-use device.

Regulatory Flags#

DUNS number
632707092
Device count
5
Lot or batch
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07325710000632Adap etCO2 Airway Neo47217882015-10-22
07325710004180CAPNOSTAT 568820782016-01-27
07325710009796CO2 ANALYZER MODULE CAPNOSTAT 568870502018-10-09
27325710011144ITS HousingPV404668827732026-03-24
27325710011601PiCCO catheterPV2015L2068850492026-03-24
27325710017047PiCCO catheterPV2013L0768850442026-03-24
27325710017061PiCCO catheterPV2014L1668850462026-03-24
27325710017092PiCCO catheterPV2014L0868850452026-03-24
07325710011140ITS HousingPV404668827732026-03-24
07325710011607PiCCO catheterPV2015L2068850492026-03-24
07325710017043PiCCO catheterPV2013L0768850442026-03-24
07325710017067PiCCO catheterPV2014L1668850462026-03-24
07325710017098PiCCO catheterPV2014L0868850452026-03-24
07325710017104PiCCO catheterPV2014L2268850472026-03-24
07325710012642Battery module68890002025-01-19
07325710001318FLOW-i C4066774002015-10-22
07325710001349FLOW-i C2066772002015-10-18
07325710001363FLOW-i C3066773002015-10-18
07325710012673Drawer for Low mobile carts68903652023-12-10
07325710001653Compressor Mini 115V 60Hz64817792023-09-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
08886483551664Safewedge(TM) Relief Valve DeviceBIOPTIMAL INTERNATIONAL PTE. LTD.KRB2026-05-20
00840682147811CARESCAPE SoftwareGE Healthcare Finland OyKRB2026-04-15
27325710011144ITS HousingMaquet Critical Care ABKRB2026-03-24
27325710011601PiCCO catheterMaquet Critical Care ABKRB2026-03-24
27325710017047PiCCO catheterMaquet Critical Care ABKRB2026-03-24
27325710017061PiCCO catheterMaquet Critical Care ABKRB2026-03-24
27325710017092PiCCO catheterMaquet Critical Care ABKRB2026-03-24
07325710011140ITS HousingMaquet Critical Care ABKRB2026-03-24
07325710011607PiCCO catheterMaquet Critical Care ABKRB2026-03-24
07325710017043PiCCO catheterMaquet Critical Care ABKRB2026-03-24
07325710017067PiCCO catheterMaquet Critical Care ABKRB2026-03-24
07325710017098PiCCO catheterMaquet Critical Care ABKRB2026-03-24
07325710017104PiCCO catheterMaquet Critical Care ABKRB2026-03-24
00690103000078CO-SET INJECTATE ICE BUCKETEdwards Lifesciences LLCKRB2025-07-16
50690103000073CO-SET INJECTATE ICE BUCKETEdwards Lifesciences LLCKRB2025-07-16
00195278522313CARESCAPE Canvas Smart DisplayGE Healthcare Finland OyKRB2023-04-19
00195278522320CARESCAPE Canvas 1000GE Healthcare Finland OyKRB2023-04-19
00195278523365CARESCAPE Canvas D19GE Healthcare Finland OyKRB2023-04-19
00195278524089NAGE Healthcare Finland OyKRB2023-04-19
00810123205080Adler Instrument CompanyAdler, Inc.KRB2023-03-03
00840682146111CARESCAPE B650GE Healthcare Finland OyKRB2022-05-13
00840682146135CARESCAPE B450GE Healthcare Finland OyKRB2022-05-13
00840682146142CARESCAPE B850GE Healthcare Finland OyKRB2022-05-13
00840682146708NAGE Medical Systems Information Technologies, Inc.KRB2022-04-12
00840682146715NAGE Medical Systems Information Technologies, Inc.KRB2022-04-12
00840682146791NAGE Medical Systems Information Technologies, Inc.KRB2022-04-12
00840682147217NAGE Medical Systems Information Technologies, Inc.KRB2022-04-12
00840682147224NAGE Medical Systems Information Technologies, Inc.KRB2022-04-12
00840619043636ICU MedicalICU MEDICAL, INC.KRB2021-10-19
10840619043633ICU MedicalICU MEDICAL, INC.KRB2021-10-19