FDA.reportPublic FDA data

BASHIR™ S-B .035 Endovascular Catheter

Primary DI
10850005115080
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
OTC
false
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
QEYMechanical Thrombolysis Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
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.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
2678983974amy@thrombolex.com

Regulatory Flags#

DUNS number
080580521
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

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
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
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00884450826201Fountain®Merit Medical Systems, Inc.QEY2026-01-16
00884450826331Fountain®Merit Medical Systems, Inc.QEY2026-01-06
10884450826338Fountain®Merit Medical Systems, Inc.QEY2026-01-06
00884450825983Fountain®Merit Medical Systems, Inc.QEY2025-12-03
10884450825980Fountain®Merit Medical Systems, Inc.QEY2025-12-03
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00884450826195Fountain®Merit Medical Systems, Inc.QEY2025-03-18
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10884450826406Fountain®Merit Medical Systems, Inc.QEY2025-02-14