FDA.reportPublic FDA data

Flexcel Carotid Shunt

Primary DI
00840663101382
Brand
Flexcel Carotid Shunt
Company
Lemaitre Vascular, Inc.
Model
2020-25
Catalog number
2020-25
Device description
Flexcel Carotid Shunt (10F)
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
MJNCatheter, Intravascular Occluding, Temporary

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MJNCatheter, Intravascular Occluding, TemporaryCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071367000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071367000FLEXCEL CAROTID SHUNT (INLYING), MODEL 2020-05LeMaitre Vascular, Inc.2007-08-29MJN

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840663101382PrimaryGS10
00840663101375Unit of UseGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840663101382008406631013828406631013820840663101382
00840663101375008406631013758406631013750840663101375

GMDN Terms#

Term, Definition table
TermDefinition
Carotid artery shuntA sterile device designed to serve as a temporary blood conduit (a shunt) connecting the distal internal carotid artery to the proximal common carotid artery allowing intravascular blood to continuously flow to the patient's brain during an endarterectomy procedure. It is typically designed as a hollow shaft with atraumatic dilations (e.g., balloons) on either end. The shaft is inserted into the lumen of the blood vessel, via a small incision at the surgical site. It is typically made of silicone elastomer and polyester radiopaque materials and is available in a range of diameters. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
781-221-2266xx@xx.xx

Regulatory Flags#

DUNS number
184805166
Device count
5
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00842429117583SCEPTERMicrovention, Inc.MJN2025-04-30
00842429106884Balloon CatheterMicrovention, Inc.MJN2025-04-22
00842429106891Balloon CatheterMicrovention, Inc.MJN2025-04-22
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00842429106945Balloon CatheterMicrovention, Inc.MJN2025-04-22
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00850001105057Prytime Medical Devices Inc.Prytime Medical Devices, Inc.MJN2022-12-15
00850001105064Prytime Medical Devices, Inc.Prytime Medical Devices, Inc.MJN2022-12-15
00842429103388Balloon CatheterMicrovention, Inc.MJN2022-06-14
00842429103395Balloon CatheterMicrovention, Inc.MJN2022-06-14
00842429103401Balloon CatheterMicrovention, Inc.MJN2022-06-14
00842429103418Balloon CatheterMicrovention, Inc.MJN2022-06-14
00842429106563Balloon CatheterMicrovention, Inc.MJN2022-06-14
00853359008414SniperEmbolx, Inc.MJN2022-05-18
16286780610016COBRA-OS™Front Line Medical Technologies Inc.MJN2022-02-09
16286780610023Syringe, 10 mLFront Line Medical Technologies Inc.MJN2022-02-09
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