FDA.reportPublic FDA data

Primum Guiding Catheter

Primary DI
08718122006160
Brand
Primum Guiding Catheter
Company
PendraCare International B.V.
Model
6F Primum JR4
Catalog number
26402804
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
2026-07-30
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
38718122006161PackageGS11In Commercial Distribution
08718122006160PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
3871812200616138718122006161
08718122006160087181220061608718122006160

Device Sizes#

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

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from sunlight
Special Storage Condition, Specify00Keep dry

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
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
08718122006153Primum Guiding Catheter6F Primum JL4264022042026-07-30
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
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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Primary DI, Brand, Company table
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07613327682458Excelsior ReachStryker CorporationDQY2026-10-29
07613327682465Excelsior ReachStryker CorporationDQY2026-10-29
07613327682496Excelsior ReachStryker CorporationDQY2026-10-29
07613327682526Excelsior ReachStryker CorporationDQY2026-10-29
07613327682571Excelsior ReachStryker CorporationDQY2026-10-29
00802526625008ACUITY™BOSTON SCIENTIFIC CORPORATIONDQY2026-10-15
0086001552773870 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
0086001552774570 NeuGlide CatheterPIRAEUS MEDICAL INC.DQY2026-10-06
00810068568998Next Generation 088 CatheterBALT USA LLCDQY2026-10-01
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00884450416723SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450422755SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450423110SureCrossMerit Medical Systems, Inc.DQY2026-09-22
00884450427170SureCrossMerit Medical Systems, Inc.DQY2026-09-22
10886704074892ENVOYCerenovus, Inc.DQY2026-09-19
08718122024218Climber Guiding CatheterPendraCare International B.V.DQY2026-05-19
00857545008394ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008400ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008431ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00857545008448ZebraQ'APEL MEDICAL LLCDQY2026-03-05
00843152100057IOPS Visionary SystemCenterline Biomedical, Inc.DQY2026-02-24
08718122013984Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122028896Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
08718122013915Primum Guiding CatheterPendraCare International B.V.DQY2026-02-02
00884450838167Ventrax™Merit Medical Systems, Inc.DQY2026-01-13
00884450838174Ventrax™Merit Medical Systems, Inc.DQY2026-01-13