FDA.reportPublic FDA data

SeQure

Primary DI
07290017268347
Brand
SeQure
Company
ACCURATE MEDICAL THERAPEUTICS LTD
Model
SQ19_SB_130
Device description
SeQure Microcatheter - 1.9 Fr., 130 cm, used with Small Beads.
Published
2021-07-22
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

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
K202797000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K202797000Drakon and Sequre MicrocathetersAccurate Medical Therapeutics, Ltd.2020-10-23DQO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290017268347PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017268347072900172683477290017268347

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
Manufacturing date on label
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
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
07290017268002SeQureSQ24_MB_1052018-08-10

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00884450766958Performa®Merit Medical Systems, Inc.DQO2026-05-28
07613327313956Trevo Trak 21Stryker CorporationDQO2020-04-17
08714729152989Impulse™BOSTON SCIENTIFIC CORPORATIONDQO2016-09-24
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