FDA.reportPublic FDA data

Bashir™ Plus Endovascular Catheter 7Fr, 12.5cm basket, 40.0cm Infusion

Primary DI
00850005115069
Brand
Bashir™ Plus Endovascular Catheter 7Fr, 12.5cm basket, 40.0cm Infusion
Company
THROMBOLEX, INC.
Model
7240
Catalog number
7240
Device description
Bashir™ Plus Endovascular Catheter 7Fr, 12.5cm basket, 40.0cm Infusion
Published
2020-02-17
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
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
K193071000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K193071000Bashir Plus Endovascular CatheterThrombolex, Inc.2019-12-17QEY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
10850005115066PackageGS116In Commercial Distribution
00850005115069PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085000511506610850005115066
00850005115069008500051150698500051150690850005115069

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular infusion catheterA sterile, flexible tube designed primarily to enable the delivery of diagnostic or therapeutic solutions into the peripheral vasculature; some types may in addition be applied to coronary or pulmonary vasculature. It is percutaneously introduced [e.g., through a guide catheter, or over-the-wire (OTW)], 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 microcatheter for access into superselective small vessels. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
267-898-3986amy@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
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
00850005115007Bashir™ Endovascular Catheter72012019-04-10
00850005115014Bashir™ N-X Endovascular Catheter72002019-04-10

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00885403523581VAMPBecton, Dickinson And CompanyKRA2026-07-31
00885403523598VAMPBecton, Dickinson And CompanyKRA2026-07-31
00885403523734VAMPBecton, Dickinson And CompanyKRA2026-07-31
00885403530565FogartyBecton, Dickinson And CompanyKRA2026-07-31
00885403542766TruWave, VAMP PlusBecton, Dickinson And CompanyKRA2026-07-31
00885403522331Swan-GanzBecton, Dickinson And CompanyKRA2026-07-24
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00884450825969Fountain®Merit Medical Systems, Inc.QEY2026-06-24
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00850013694099MicroGuideMicro Medical Solutions, Inc.KRA2026-04-24
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00812339030319Pounce Venous Thrombectomy SystemSurmodics, Inc.KRA2023-10-27
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00763000399689PhenomTM 21 CatheterMicro Therapeutics, Inc.KRA2021-04-26
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