FDA.reportPublic FDA data

Convey

Primary DI
08714729798637
Brand
Convey
Company
PendraCare International B.V.
Model
5FConvey IM
Catalog number
H74939228260
Device description
The Hydrophilic Coated Guiding Catheter is a single use device that facilitates the passage of intravascular devices.
Published
2016-05-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K120585000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K120585000CONVEY GUIDING CATHETERPendracare International, B.V.2012-08-08DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729798637PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729798637087147297986378714729798637

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), 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
Device Size Text, specify0
Length100Centimeter

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from Sunlight
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature10 Degrees Celsius40 Degrees Celsius

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
888-272-1001xxx@xx.xx

Regulatory Flags#

DUNS number
413008652
Device count
1
Lot or batch
true
Expiration date on label
true

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
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
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

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Primary DI, Brand, Company table
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