FDA.reportPublic FDA data

Bendit®21 Microcatheter

Primary DI
17290018072049
Brand
Bendit®21 Microcatheter
Company
BEND IT TECHNOLOGIES LTD
Model
BDT21157U2
Device description
The Bendit®21 Microcatheter is intended for use in accessing target locations in the peripheral, coronary, and neuro vasculature and can be used to deliver both diagnostic agents, such as contrast media, and therapeutic devices.Use only contrast media and therapeutic devices that have been cleared or approved for use in the intended target area.
Published
2022-06-09
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
DQYCatheter, Percutaneous
QJPCatheter, Percutaneous, Neurovasculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2
QJPCatheter, Percutaneous, NeurovasculatureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K203842000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K203842000Bendit21 MicrocatheterBend IT Technologies, Ltd.2022-04-13QJP

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
27290018072046PackageGS11In Commercial Distribution
17290018072049PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized table
Source identifierGTIN-14 normalized
2729001807204627290018072046
1729001807204917290018072049

GMDN Terms#

Term, Definition table
TermDefinition
Vascular microcatheterA sterile, small-diameter, single-lumen, flexible tube designed for the controlled infusion of fluids (e.g., thrombolytics, diagnostic contrast media) into superselective small vessels (including intracranial, peripheral, or occluded coronary vasculature) for angiography/treatment, and typically also for the delivery of devices (e.g., embolization implants, guidewires) into tortuous vessels or across tight lesions. It may include an ultrasound transducer, a thermal sensor, and a hole for guidewire placement located at the distal tip. It is not a guide-catheter (i.e., is not intended to deliver other catheters or therapeutic leads directly through its lumen). This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
13152073508info@bendittech.com

Regulatory Flags#

DUNS number
600476669
Device count
1
Lot or batch
true
Serial number
true
Manufacturing date on label
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
17290018072001Bendit2.7 Steerable MicrocatheterBDT012002020-08-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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07613327623352AXS LiftStryker CorporationQJP2025-03-04
07613327623376AXS LiftStryker CorporationDQY2025-03-04
07613327623390AXS LiftStryker CorporationQJP2025-03-04
00842429106563Balloon CatheterMicrovention, Inc.DQY2022-06-14
00763000539351RebarMicro Therapeutics, Inc.QJP2022-02-27
07613327519372AXS VECTA 46Stryker CorporationQJP2021-12-17
07613327313956Trevo Trak 21Stryker CorporationQJP2020-04-17
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