FDA.reportPublic FDA data

PiCCO catheter

Primary DI
07325710017067
Brand
PiCCO catheter
Company
Maquet Critical Care AB
Model
PV2014L16
Catalog number
6885046
Published
2026-03-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
false
OTC
false
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
27325710017061PrimaryGS10
07325710017067Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
2732571001706127325710017061
07325710017067073257100170677325710017067

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
632707092
Device count
5
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
true
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
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
27325710017108PiCCO catheterPV2014L2268850472026-03-24
07325710011140ITS HousingPV404668827732026-03-24
07325710011607PiCCO catheterPV2015L2068850492026-03-24
07325710017043PiCCO catheterPV2013L0768850442026-03-24
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
27325710017108PiCCO 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
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