FDA.reportPublic FDA data

Flouropassiv™

Primary DI
05037881003238
Brand
Flouropassiv™
Company
VASCUTEK LTD
Model
921020FTS
Catalog number
921020FTS
Device description
Fluoropassiv Gelatin Impregnated Thin Wall Knitted Carotid Patch VS125 TAPERED PATCH
Published
2015-10-22
Public version status
Update
Distribution status
Not 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
DXZPATCH, PLEDGET AND INTRACARDIAC, PETP, PTFE, POLYPROPYLENE

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXZPatch, Pledget And Intracardiac, Petp, Ptfe, PolypropyleneCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K972201000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K972201000PATCH,PLEDGET AND INTRACARDIAC,PETP,PTFE,POLYPROPYLENESulzer Carbomedics, Inc.1998-04-14DXZ

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
05037881003238PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
05037881003238050378810032385037881003238

GMDN Terms#

Term, Definition table
TermDefinition
Cardiovascular patch, animal-derivedA sterile implantable material designed to reinforce suture lines and/or increase the strength of weak or injured cardiac and/or peripheral vascular tissues during cardiovascular repair/reconstruction procedures (e.g., annulus or septal defect repair, endarterectomy, profundaplasty). It is a patch made of, or coated/impregnated with, materials of animal origin (e.g., porcine, bovine, or equine pericardium/collagen), that is typically implanted with sutures.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Device Size Text, specify0

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Handling Environment Temperature0 Degrees Celsius35 Degrees Celsius
Special Storage Condition, Specify00Store in a clean dry area

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
+1(800)262-3304xx@xx.xx

Regulatory Flags#

DUNS number
229053087
Device count
1
Lot or batch
true
Serial number
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
05037881184883Gelweave Vascular Prostheses73241288/10QRME73241288/10QRME2026-05-22
05037881184890Gelweave Vascular Prostheses73241288/10QRME73241288/10QRME2026-05-22
05037881184906Gelweave Vascular Prostheses73241288/10QRME73241288/10QRME2026-05-22
05037881184913Gelweave Vascular Prostheses73241288/10QRME73241288/10QRME2026-05-22
05037881184920Gelweave Vascular Prostheses73241288/10QRME73241288/10QRME2026-05-22
05037881184937Gelweave Vascular Prostheses73241288/10QRME73241288/10QRME2026-05-22
05037881026626Thoraflex™ HybridTHP2224X100ATHP2224X100A2022-05-31
05037881026695Thoraflex™ HybridTHP2426X100ATHP2426X100A2022-05-31
05037881026725Thoraflex™ HybridTHP3032X100ATHP3032X100A2022-05-31
05037881026756Thoraflex™ HybridTHP3038X100ATHP3038X100A2022-05-31
05037881026800Thoraflex™ HybridTHP2628X150ATHP2628X150A2022-05-31
05037881026848Thoraflex™ HybridTHP3036X150ATHP3036X150A2022-05-31
05037881026923Thoraflex™ HybridTHA2830X100ATHA2830X100A2022-05-31
05037881026947Thoraflex™ HybridTHA3034X100ATHA3034X100A2022-05-31
05037881027029Thoraflex™ HybridTHA2830X150ATHA2830X150A2022-05-31
05037881027067Thoraflex™ HybridTHA3038X150ATHA3038X150A2022-05-31
05037881027074Thoraflex™ HybridTHA3040X150ATHA3040X150A2022-05-31
05037881031712Thoraflex™ HybridTHP2224X100BTHP2224X100B2025-09-04
05037881031729Thoraflex™ HybridTHP2426X100BTHP2426X100B2025-09-04
05037881031736Thoraflex™ HybridTHP2628X100BTHP2628X100B2025-09-04

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10888439624281CARDINAL HEALTHCardinal Health 200, LLCDXZ2019-12-16
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14026704646750DEKNATELTELEFLEX INCORPORATEDDXZ2019-11-20
14026704646767DEKNATELTELEFLEX INCORPORATEDDXZ2019-11-20
14026704646781DEKNATELTELEFLEX INCORPORATEDDXZ2019-11-20
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10705031462212ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462229ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462281ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462304ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462335ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462359ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462366ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462373ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
10705031462403ETHIBOND EXCELETHICON, LLCDXZ2019-07-04
00859389005102Tyke, Patch, Pledget and IntracardiacElutia Med LLCDXZ2019-02-28
14026704638540DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638557DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638564DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
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14026704638588DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638601DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638618DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638625DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638632DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638649DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
14026704638656DEKNATELTELEFLEX INCORPORATEDDXZ2018-12-03
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