FDA.reportPublic FDA data

SeQure

Primary DI
07290017268002
Brand
SeQure
Company
ACCURATE MEDICAL THERAPEUTICS LTD
Model
SQ24_MB_105
Device description
SeQure Microcatheter - 2.4 Fr, 105cm, used with Medium Beads
Published
2018-08-10
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

Product Codes#

Code, Name table
CodeName
DQOCatheter, Intravascular, Diagnostic

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQOCatheter, Intravascular, DiagnosticCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K173430000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K173430000SeQure® NF and SeQure® MicrocathetersAccurate Medical Therapeutics, Ltd.2018-01-26DQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290017268002PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017268002072900172680027290017268002

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.

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Avoid exposure to water, direct sunlight, extreme temperature or humidity during storage.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
532177871
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290017268316SeQureSQ17_SB_1302021-07-22
07290017268323SeQureSQ17_SB_1552021-07-22
07290017268330SeQureSQ19_SB_1052021-07-22
07290017268347SeQureSQ19_SB_1302021-07-22
07290017268354SeQureSQ19_SB_1552021-07-22
07290017268361SeQureSQ27_XSB_1302021-07-22
07290017268378SeQureSQ27_XSB_1552021-07-22
07290017268385SeQureSQ30_XLB_1052021-07-22
07290017268392SeQureSQ30_XLB_1302021-07-22
07290017268408SeQureSQ30_XLB_1552021-07-22
07290017268804DrakonDK17_1052021-07-22
07290017268811DrakonDK17_1302021-07-22
07290017268828DrakonDK17_1552021-07-22
07290017268866DrakonDK30_1052021-07-22
07290017268873DrakonDK30_1302021-07-22
07290017268880DrakonDK30_1552021-07-22
07290017268309SeQureSQ17_SB_1052021-07-22
07290017268835DrakonDK19_1052021-07-22
07290017268842DrakonDK19_1302021-07-22
07290017268859DrakonDK19_1552021-07-22

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885403522270Swan-GanzBecton, Dickinson And CompanyDQO2026-05-30
00885403522386Swan-GanzBecton, Dickinson And CompanyDQO2026-05-30
00884450766958Performa®Merit Medical Systems, Inc.DQO2026-05-28
07613327313956Trevo Trak 21Stryker CorporationDQO2020-04-17
08714729152989Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729188865Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729200291Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213161Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213178Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213185Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213192Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213208Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213369Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213666Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213741Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213888Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729213918Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214007Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214083Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214120Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214168Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214243Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214342Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214380Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214441Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214472Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214502Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214632Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214656Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
08714729214663Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24