FDA.reportPublic FDA data

Primum Guiding Catheter

Primary DI
08718122013915
Brand
Primum Guiding Catheter
Company
PendraCare International B.V.
Model
6F Primum JL3.5
Catalog number
26102104
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.
Published
2026-02-02
Public version status
Update
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
38718122013916PackageGS15In Commercial Distribution
08718122013915PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3871812201391638718122013916
08718122013915087181220139158718122013915

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. It is not intended solely for infusion nor to access superselective small vessels, and does not include a transseptal needle. A percutaneous introduction set, shaft visualization electrodes, or haemostatic valve may be supplied with the guide-catheter. This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Catheter Length0
Device Size Text, specify0

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
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
08718122013984Primum Guiding Catheter6F Primum JR4261028042026-02-02
08718122028896Primum Guiding Catheter6F Primum EBU3.5261088042026-02-02
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
08718122024218Climber Guiding CatheterEBU3.75GC-P6EB370N2026-05-19
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

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