Climber Guiding Catheter

Primary DI
08718122024218
Brand
Climber Guiding Catheter
Company
PendraCare International B.V.
Model
EBU3.75
Catalog number
GC-P6EB370N
Device description
The guiding catheter (GC) will consist of a reinforced body with a hub and strain relief at the proximal end and an intermediate and soft tip at the distal end. The distal part of the catheter features a specific tip shape. A part of the catheter body features a hydrophilic coating. The GC is developed with or without side holes. The Design Inputs and Design Outputs are gathered in attachment 1 (Design Input – Design Output Table) per SOP R&D-006 (Design Input – Design Output).
Published
2026-05-19
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K250972000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K250972000Primum Hydrophilic Guiding CatheterPendracare2025-06-29DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
38718122024219PackageGS11In Commercial Distribution
08718122024218PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3871812202421938718122024219
08718122024218087181220242188718122024218

GMDN Terms#

Term, Definition table
TermDefinition
Vascular guide-catheter, single-useA flexible tube intended to be used for the percutaneous transluminal passage and placement of a diagnostic/interventional catheter, lead (e.g., pacing lead, balloon dilatation catheter), needle or guidewire through its lumen(s), within the vascular system. It may be rigid or flexible, non-steerable or steerable, single or multiple lumen(s), and the distal section can have a variety of preformed shapes (e.g., straight, hockey stick). It is not intended solely for infusion, is not intended to access superselective small vessels, and does not include a transseptal needle. It may include a disposable percutaneous introduction set or shaft visualization electrodes. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Length100Centimeter
Device Size Text, specify0

Regulatory Flags#

DUNS number
413008652
Device count
1
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
08718122006153Primum Guiding Catheter6F Primum JL4264022042026-07-30
08718122006160Primum Guiding Catheter6F Primum JR4264028042026-07-30
08718122008188Primum Guiding Catheter6F Primum EBU3.5264088042026-07-30
08718122008195Primum Guiding Catheter6F Primum EBU3.5 SH264088242026-07-30
08718122013922Primum Guiding Catheter6F Primum JL4261022042026-07-30
08718122014103Primum Guiding Catheter6F Primum JL4 SH261022242026-07-30
08718122028902Primum Guiding Catheter6F Primum EBU3.5 SH261088242026-07-30
08718122013984Primum Guiding Catheter6F Primum JR4261028042026-02-02
08718122028896Primum Guiding Catheter6F Primum EBU3.5261088042026-02-02
08718122013915Primum Guiding Catheter6F Primum JL3.5261021042026-02-02
38718122013985Primum Guiding Catheter6F Primum JR4261028042026-02-02
38718122028897Primum Guiding Catheter6F Primum EBU3.5261088042026-02-02
08714729797876Convey5FConvey JL3H7493922866002016-05-01
08714729797883Convey5FConvey JL3.5H7493922866102016-05-01
08714729797890Convey5FConvey JL4H7493922866202016-05-01
08714729797906Convey5FConvey JL4.5H7493922866302016-05-01
08714729797913Convey5FConvey JL5H7493922866402016-05-01
08714729797920Convey5FConvey JL6H7493922866502016-05-01
08714729797937Convey5FConvey FL3H749392280502016-05-01
08714729797944Convey5FConvey FL3.5H749392280602016-05-01

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