7 Fr PV-Catheter

Primary DI
08719327737347
Brand
7 Fr PV-Catheter
Company
CD Leycom
Model
CA-71123-PL
Catalog number
CDL018
Device description
7 Fr PV-Loop catheter with 12 mm electrode spacing
Published
2023-09-20
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQOCatheter, Intravascular, Diagnostic
OBJCatheter, Ultrasound, Intravascular

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2
OBJCatheter, Ultrasound, IntravascularCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K030524000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K030524000CD LEYCOM 7 FR PRESSURE/VOLUME CATHETER (10 MM ELECTRODE SPACING) PRESSURE/VOLUME COMBINATION CATHETER WITH LUMENCd Leycom BV2003-03-03OBJ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08719327737347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719327737347087193277373478719327737347

GMDN Terms#

Term, Definition table
TermDefinition
Intracardiac catheter-tip electrodeAn electrical conductor located at one end of an appropriate flexible catheter (not included) which is inserted into the chambers of the heart in order for the electrode to detect the presence of certain indicators to measure cardiac output. The relayed signals from the electrode can help the operator determine the presence of left-to-right heart shunt. The electrical conductor may also be used to characterize the electrical activity of the heart. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
414947457
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
08717953256645Cardiac Function LaboratoryCFL-M IncaCDL0012023-09-20
087193277373094 Fr PV CatheterCA-41063-PNCDL0142023-09-20
087193277373164 Fr PV CatheterCA-41103-PNCDL0152023-09-20
087193277373237 Fr PV-CatheterCA-71083-PLCDL0162023-09-20
087193277373307 Fr PV-CatheterCA-71103-PLCDL0172023-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00842429108574BOBBY/SOFIA KitMicrovention, Inc.DQO2025-04-30
00842429108444SofiaMicrovention, Inc.DQO2024-10-18
00842429108451SofiaMicrovention, Inc.DQO2024-10-18
00842429108468SofiaMicrovention, Inc.DQO2024-10-18
00763000541194RistTMMicro Therapeutics, Inc.DQO2022-05-01
00763000541200RistTMMicro Therapeutics, Inc.DQO2022-05-01
00763000541217RistTMMicro Therapeutics, Inc.DQO2022-05-01
00763000413767Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413774Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413781Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413798Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413804Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413811Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413828Rist™Micro Therapeutics, Inc.DQO2020-10-05
00816777025913Sofia 5F-125cm STRMicrovention, Inc.DQO2018-08-07
00816777025920Sofia 5F-115cm STRMicrovention, Inc.DQO2018-08-07
00857688007278Respiguide Delivery SystemRESPICARDIA, INC.DQO2018-04-30
00884450089194EmboCath® PlusBIOSPHERE MEDICALDQO2017-05-11
00884450089200EmboCath® PlusBIOSPHERE MEDICALDQO2017-05-11
00866749000202Morph Universal Deflectable Guide CatheterBIOCARDIA, INC.DQO2016-10-10
08714729200567Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200574Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200581Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200598Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200604Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200611Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200628Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200635Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200659Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200666Wiseguide ™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24