FDA.reportPublic FDA data

BASHIR™ S-B .035 Endovascular Catheter

Primary DI
00850005115083
Brand
BASHIR™ S-B .035 Endovascular Catheter
Company
THROMBOLEX, INC.
Model
8101
Catalog number
8101
Device description
Bashir™ .035 S-B Endovascular Catheter 8Fr, 10.0cm 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
10850005115080PackageGS116In Commercial Distribution
00850005115083PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000511508010850005115080
00850005115083008500051150838500051150830850005115083

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.

Contacts#

Phone, Email table
PhoneEmail
2678983974amy@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
00850005115076BASHIR™ .035 Endovascular Catheter820182012023-12-11
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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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G4533352797GM8M50PEAK MEDICALPeak Medical Distribution Inc.KRA2026-05-27
15051684023801Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
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15051684023832Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023849Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023856Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023863Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023870Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023887Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023894Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023900Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023924Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023931Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
15051684023948Uni-Fuse+Angiodynamics, Inc.KRA2024-08-01
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07640132622706M-CATH Flexy Acrostak (Schweiz) AGKRA2021-11-01
07640132622157M-CATH MicrocatheterAcrostak (Schweiz) AGKRA2018-05-15
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