FDA.reportPublic FDA data

Convey

Primary DI
08714729853336
Brand
Convey
Company
PendraCare International B.V.
Model
8F Convey LeftBU3.25
Catalog number
H749392667290
Device description
The Hydrophilic Coated Guiding Catheter is a single use device that facilitates the passage of intravascular devices. No(0) Side Holes in the Tip Section.
Published
2016-05-01
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
OTC
false
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
K132197000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K132197000CONVEY 7F GUIDING CATHETER, CONVEY 8F GUIDING CATHETERPendracare International, B.V.2013-08-12DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729853336PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729853336087147298533368714729853336

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
Device Size Text, specify0
Device Size Text, specify0
Length0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Keep away from Sunlight
Special Storage Condition, Specify00Keep dry
Storage Environment Temperature00

Contacts#

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

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
false
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
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
08718122024218Climber Guiding CatheterEBU3.75GC-P6EB370N2026-05-19
08718122028896Primum Guiding Catheter6F Primum EBU3.5261088042026-02-02
08718122013915Primum Guiding Catheter6F Primum JL3.5261021042026-02-02
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

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Primary DI, Brand, Company table
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