FDA.reportPublic FDA data

BASHIR™ .035 Endovascular Catheter

Primary DI
00850005115076
Brand
BASHIR™ .035 Endovascular Catheter
Company
THROMBOLEX, INC.
Model
8201
Catalog number
8201
Device description
Bashir™ .035 Endovascular Catheter 8Fr, 12.5cm basket
Published
2023-12-11
Public version status
New
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
KRACatheter, Continuous Flush
QEYMechanical Thrombolysis Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRACatheter, Continuous FlushCardiovascular2
QEYMechanical Thrombolysis CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K231653000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K231653000BASHIR™ .035 Endovascular Catheter, BASHIR™ S-B .035 Endovascular CatheterThrombolex, Inc.2023-07-03QEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850005115073PackageGS116In Commercial Distribution
00850005115076PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000511507310850005115073
00850005115076008500051150768500051150760850005115076

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular intervention infusion catheterA flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature during a cardiovascular procedure (e.g., delivery of an antithrombotic agent); some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced and may include features such as side holes for infusion across a specific region, an expanding frame to disrupt clotted blood to improve diffusion, or a balloon to support infusion at a specific region. It is neither a peripherally-inserted central venous catheter, dedicated occluding catheter, nor superselective small vessel microcatheter. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2678983947amy@thrombolex.com

Regulatory Flags#

DUNS number
080580521
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850005115083BASHIR™ S-B .035 Endovascular Catheter810181012023-12-11
10850005115080BASHIR™ S-B .035 Endovascular Catheter810181012023-12-11
00850005115021Bashir™ S-B Endovascular Catheter 7Fr, 10.0cm basket710171012020-02-17
00850005115038Bashir™ Plus Endovascular Catheter 7Fr, 12.5cm basket, 10.0cm Infusion721072102020-02-17
00850005115045Bashir™ Plus Endovascular Catheter 7Fr, 12.5cm basket, 20.0cm Infusion722072202020-02-17
00850005115052Bashir™ Plus Endovascular Catheter 7Fr, 12.5cm basket, 30.0cm Infusion723072302020-02-17
00850005115069Bashir™ Plus Endovascular Catheter 7Fr, 12.5cm basket, 40.0cm Infusion724072402020-02-17
00850005115007Bashir™ Endovascular Catheter72012019-04-10
00850005115014Bashir™ N-X Endovascular Catheter72002019-04-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00860009303423Powered Aventus Clot Management SystemInquis Medical, Inc.KRA2026-10-19
00860009303461C02 Cartridge AccessoryInquis Medical, Inc.KRA2026-10-19
00860009303492Powered Aventus Thrombectomy Catheter, 16F, 115cmInquis Medical, Inc.KRA2026-10-19
00860014559259C02 Cartridge Accessory - 5 PackInquis Medical, Inc.KRA2026-10-19
00860014559273Powered Aventus Thrombectomy CatheterInquis Medical, Inc.KRA2026-10-19
05391547390019InVera Infusion DeviceINVERA MEDICAL LIMITEDKRA2026-10-09
00850044140022Helo Max Thrombectomy SystemEndovascular Engineering, Inc.KRA2026-09-29
00857136004293TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004392TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004408TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00857136004415TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.KRA2026-09-24
00885403542667TRUWAVEBecton, Dickinson And CompanyKRA2026-09-05
00850013694099MicroGuideMicro Medical Solutions, Inc.KRA2026-04-24
00810123710393ClotTriever BOLD CatheterInari Medical, Inc.KRA2025-04-09
00810123710577Artix Thin-Walled SheathInari Medical, Inc.KRA2024-11-11
00810123710560Artix Thin-Walled SheathInari Medical, Inc.KRA2024-11-07
B0902P0130B0Knight MicrocatheterZien Medical Technologies, LLCKRA2024-04-30
B0902P0130S0Knight MicrocatheterZien Medical Technologies, LLCKRA2024-04-30
B090E20130B0XO CathZien Medical Technologies, LLCKRA2024-04-30
B090E20130S0XO CathZien Medical Technologies, LLCKRA2024-04-30
00810123710140ClotTriever CatheterInari Medical, Inc.KRA2024-04-17
00850291007406VenaCore Thrombectomy CatheterInari Medical, Inc.KRA2024-03-27
00810123710430ClotTriever SheathInari Medical, Inc.KRA2023-12-15
00810123710522Triever20 CurveInari Medical, Inc.KRA2023-12-15
00812339030319Pounce Venous Thrombectomy SystemSurmodics, Inc.KRA2023-10-27
00850291007369InThrill SheathInari Medical, Inc.KRA2023-07-18
00850291007277ClotTriever XL CatheterInari Medical, Inc.KRA2023-05-09
00850291007376Artix AXInari Medical, Inc.KRA2023-04-24
00850291007222Protrieve SheathInari Medical, Inc.KRA2023-03-20
00812339030302Pounce™ Venous Thrombectomy SystemSurmodics, Inc.KRA2022-06-22