FDA.reportPublic FDA data

7 Fr PV-Catheter

Primary DI
08719327737330
Brand
7 Fr PV-Catheter
Company
CD Leycom
Model
CA-71103-PL
Catalog number
CDL017
Device description
7 Fr PV Loop catheter with 10 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
08719327737330PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08719327737330087193277373308719327737330

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
087193277373477 Fr PV-CatheterCA-71123-PLCDL0182023-09-20

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00885403522270Swan-GanzBecton, Dickinson And CompanyDQO2026-05-30
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00884450766958Performa®Merit Medical Systems, Inc.DQO2026-05-28
00690103218602SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQO2026-03-16
00690103218626SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQO2026-03-16
00690103218633SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQO2026-03-16
07613327664096Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OBJ2025-02-11
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07613327664119Philips HealthcareSTRYKER SUSTAINABILITY SOLUTIONS, INC.OBJ2025-02-11
04068151012477ACUSON Origin ICE Diagnostic Ultrasound SystemSIEMENS MEDICAL SOLUTIONS USA, INC.OBJ2024-08-22
04056869996295ACUSON Origin Diagnostic Ultrasound SystemSIEMENS MEDICAL SOLUTIONS USA, INC.OBJ2023-12-19
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