FDA.reportPublic FDA data

SeQure

Primary DI
07290017268354
Brand
SeQure
Company
ACCURATE MEDICAL THERAPEUTICS LTD
Model
SQ19_SB_155
Device description
SeQure Microcatheter - 1.9 Fr., 155 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
07290017268354PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017268354072900172683547290017268354

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
07290017268361SeQureSQ27_XSB_1302021-07-22
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
07290017268019SeQureSQ24_MB_1302018-08-10
07290017268026SeQureSQ24_MB_1502018-08-10

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10841156112035LANGSTONTELEFLEX INCORPORATEDDQO2026-06-26
00884450787663Impress®Merit Medical Systems, Inc.DQO2026-06-08
00885403522270Swan-GanzBecton, Dickinson And CompanyDQO2026-05-30
00885403522386Swan-GanzBecton, Dickinson And CompanyDQO2026-05-30
00884450766958Performa®Merit Medical Systems, Inc.DQO2026-05-28
00690103218602SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQO2026-03-16
00690103218626SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQO2026-03-16
00690103218633SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCDQO2026-03-16
07290017268316SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268323SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268330SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268361SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268385SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268392SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268408SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268804DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268811DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268828DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268866DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268873DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268880DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268309SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268835DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268842DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268859DrakonACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07613327313956Trevo Trak 21Stryker CorporationDQO2020-04-17
07290017268002SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2018-08-10
07290017268019SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2018-08-10
07290017268026SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2018-08-10
07290017268033SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2018-08-10