FDA.reportPublic FDA data

Primum Guiding Catheter

Primary DI
38718122013985
Brand
Primum Guiding Catheter
Company
PendraCare International B.V.
Model
6F Primum JR4
Catalog number
26102804
Device description
The Hdrophilic Coated Gudidng Catheter is a single use device that facilitates the passage of intravascualar devices. Also available with two (2) Side Holes in the tip section.
Published
2026-02-02
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
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
38718122013985PackageGS15In Commercial Distribution
08718122013984PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3871812201398538718122013985
08718122013984087181220139848718122013984

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
413008652
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true
Donation ID number
true
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
08718122024218Climber Guiding CatheterEBU3.75GC-P6EB370N2026-05-19
08718122013984Primum Guiding Catheter6F Primum JR4261028042026-02-02
08718122028896Primum Guiding Catheter6F Primum EBU3.5261088042026-02-02
08718122013915Primum Guiding Catheter6F Primum JL3.5261021042026-02-02
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
08714729797951Convey5FConvey FL4H749392280702016-05-01
08714729797968Convey5FConvey FL4.5H749392280802016-05-01
08714729797975Convey5FConvey FL5H749392280902016-05-01
08714729797982Convey5FConvey FL6H749392281002016-05-01
08714729797999Convey5FConvey FCL3H7493922872502016-05-01
08714729798002Convey5FConvey FCL3.5H7493922827202016-05-01
08714729798019Convey5FConvey FCL4H7493922827302016-05-01

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Primary DI, Brand, Company table
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00810024671953SSPC NXT Delivery CatheterCENTERPOINT SYSTEMS LLCDQY2026-06-01
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