FDA.reportPublic FDA data

MultiTASC Dissection/Transection Device sizing tool

Primary DI
00840663105908
Brand
MultiTASC Dissection/Transection Device sizing tool
Company
Lemaitre Vascular, Inc.
Model
4500-50
Catalog number
4500-50
Device description
MultiTASC Dissection/Transection Device sizing tool
Published
2015-07-15
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
DWXStripper, Artery, Intraluminal

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DWXStripper, Artery, IntraluminalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K121415000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K121415000MOLLRING MULTITASCLeMaitre Vascular, Inc.2012-09-05DWX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00840663105908PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00840663105908008406631059088406631059080840663105908

GMDN Terms#

Term, Definition table
TermDefinition
Intraluminal artery stripper, reusableA hand-held manual surgical instrument designed to perform an endarterectomy (the removal of plaque deposits from arteriosclerotic arteries) during a vasculature reconstruction procedure. It is typically made of high-grade stainless steel and is available in various designs including the "MollRing cutter". Indications for its use include disabling claudication, ischemic pain at rest, ischemic skin lesions, or gangrene. This is a reusable 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
00763000358822NAMEDTRONIC, INC.DWX2020-02-17
10885403034992V. MuellerCAREFUSION 2200, INCDWX2016-09-23
04953170047671VALVULOTOME (DETACHABLE TYPE)OLYMPUS MEDICAL SYSTEMS CORP.DWX2016-09-21
04953170047695VALVULOTOME (DETACHABLE TYPE)OLYMPUS MEDICAL SYSTEMS CORP.DWX2016-09-21
14953170047678VALVULOTOME (DETACHABLE TYPE)OLYMPUS MEDICAL SYSTEMS CORP.DWX2016-09-21
14953170047692VALVULOTOME (DETACHABLE TYPE)OLYMPUS MEDICAL SYSTEMS CORP.DWX2016-09-21
24026704518955PILLINGTELEFLEX INCORPORATEDDWX2016-09-16
24026704518962PILLINGTELEFLEX INCORPORATEDDWX2016-09-16
04026704518944PillingTELEFLEX INCORPORATEDDWX2016-09-16
04026704518951PillingTELEFLEX INCORPORATEDDWX2016-09-16
04026704518968PillingTELEFLEX INCORPORATEDDWX2016-09-16
00840663102693MollRing Cutter Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663102709MollRing Cutter Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663102716MollRing Cutter Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663102723MollRing Cutter Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663102730MollRing Cutter Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663102747MollRing Cutter Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663105823MultiTASC Dissection/Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663105830MultiTASC Dissection/Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663105847MultiTASC Dissection/Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663105854MultiTASC Dissection/Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663105861MultiTASC Dissection/Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663105878MultiTASC Dissection/Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663105885MultiTASC Dissection/Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663105892MultiTASC Dissection/Transection DeviceLemaitre Vascular, Inc.DWX2015-07-15
00840663102563Periscope DissectorLemaitre Vascular, Inc.DWX2015-06-30
00840663102570Martin DissectorLemaitre Vascular, Inc.DWX2015-06-30
00840663102587EndoHelix Retrieval DeviceLemaitre Vascular, Inc.DWX2015-06-30