FDA.reportPublic FDA data

Polyurethane Dual Lumen Occlusion Catheter

Primary DI
00840663102280
Brand
Polyurethane Dual Lumen Occlusion Catheter
Company
Lemaitre Vascular, Inc.
Model
5F-2L-80
Catalog number
5F-2L-80
Device description
Polyurethane Dual Lumen Occlusion Catheter, 5F, 80cm
Published
2015-06-30
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQTOccluder, Catheter Tip

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQTOccluder, Catheter TipCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K844918000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K844918000OCCLUSION & OCCLUSION-IRRIGATIONClincal Instruments Corp.1985-08-05DQT

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840663102280PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840663102280008406631022808406631022800840663102280

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular occluding balloon catheter, image-guidedA flexible tube with an inflatable balloon(s) at the distal end intended to be introduced short-term under image guidance to temporarily block a blood vessel. It may be used for arteriography, selective angiography, preoperative occlusion, peripheral and intracranial vasculature occlusion, emergency control of haemorrhage, to treat malformations (e.g., aneurysms), chemotherapeutic drug infusion, and renal opacification procedures. It may have a dual- or multi-lumen design, one for balloon inflation and another to pass it over a guidewire, or for the infusion of contrast medium, delivery of a smaller catheter, or embolic agents. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
781-221-2266csus@lemaitre.com

Regulatory Flags#

DUNS number
184805166
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00840663110360AlboGraft Polyester Vascular Graft ATC6034ATC60342021-06-18
00840663110377AlboGraft Polyester Vascular Graft ATC6038ATC60382021-06-18
00840663110384AlboGraft Polyester Vascular Graft ATC1206ATC12062021-06-18
00840663102815AlboGraft Polyester Vascular GraftAMC1506AMC15062015-07-30
00840663102839AlboGraft Polyester Vascular Graft AMC4006AMC40062015-10-16
00840663102846AlboGraft Polyester Vascular GraftAMC6006AMC60062015-10-16
00840663102853AlboGraft Polyester Vascular GraftAMC1006AMC10062015-10-16
00840663102860AlboGraft Polyester Vascular GraftAMC4007AMC40072015-10-16
00840663102877AlboGraft Polyester Vascular GraftAMC1508AMC15082015-10-16
00840663102884AlboGraft Polyester Vascular GraftAMC3008AMC30082015-10-16
00840663102891AlboGraft Polyester Vascular Graft AMC4008AMC40082015-10-16
00840663102907AlboGraft Polyester Vascular Graft AMC6007AMC60072015-10-16
00840663102914AlboGraft Polyester Vascular Graft AMC6008AMC60082015-10-16
00840663102921AlboGraft Polyester Vascular Graft AMC1008AMC10082015-10-16
00840663102938AlboGraft Polyester Vascular Graft AMC1510AMC15102015-10-16
00840663102945AlboGraft Polyester Vascular Graft AMC3010AMC30102015-10-16
00840663102952AlboGraft Polyester Vascular Graft AMC4010AMC40102015-10-16
00840663102969AlboGraft Polyester Vascular Graft AMC6010AMC60102015-10-16
00840663102976AlboGraft Polyester Vascular Graft AMC1010AMC10102015-10-16
00840663102983AlboGraft Polyester Vascular Graft AMC1512AMC15122015-10-16

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00840663101511Pruitt Aortic Occlusion CatheterLemaitre Vascular, Inc.DQT2015-06-30
00840663101528Pruitt Aortic Occlusion CatheterLemaitre Vascular, Inc.DQT2015-06-30
00840663101535Pruitt Irrigation Occlusion CatheterLemaitre Vascular, Inc.DQT2015-06-30
00840663101542Pruitt Irrigation Occlusion CatheterLemaitre Vascular, Inc.DQT2015-06-30
00840663102259Polyurethane Dual Lumen Occlusion CatheterLemaitre Vascular, Inc.DQT2015-06-30
00840663102266Polyurethane Dual Lumen Occlusion CatheterLemaitre Vascular, Inc.DQT2015-06-30
00840663102273Polyurethane Dual Lumen Occlusion CatheterLemaitre Vascular, Inc.DQT2015-06-30