FDA.reportPublic FDA data

SeQure

Primary DI
07290017268316
Brand
SeQure
Company
ACCURATE MEDICAL THERAPEUTICS LTD
Model
SQ17_SB_130
Device description
SeQure Microcatheter - 1.7 Fr., 130 cm, used with Small Beads
Published
2021-07-22
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
07290017268316PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
07290017268316072900172683167290017268316

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.

Regulatory Flags#

DUNS number
532177871
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
true
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
07290017268347SeQureSQ19_SB_1302021-07-22
07290017268354SeQureSQ19_SB_1552021-07-22
07290017268378SeQureSQ27_XSB_1552021-07-22
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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450836316Performa®Merit Medical Systems, Inc.DQO2026-10-07
00857136004293TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00857136004392TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00857136004408TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00857136004415TriNav Advance Infusion SystemSUREFIRE MEDICAL, INC.DQO2026-09-24
00884450787793Impress®Merit Medical Systems, Inc.DQO2026-09-18
00884450788868Impress®Merit Medical Systems, Inc.DQO2026-09-18
00842429108574BOBBY/SOFIA KitMicrovention, Inc.DQO2025-04-30
00842429108444SofiaMicrovention, Inc.DQO2024-10-18
00842429108451SofiaMicrovention, Inc.DQO2024-10-18
00842429108468SofiaMicrovention, Inc.DQO2024-10-18
10801902208580ARROWTELEFLEX INCORPORATEDDQO2024-02-05
10801902208542ARROWTELEFLEX INCORPORATEDDQO2023-06-12
10801902208559ARROWTELEFLEX INCORPORATEDDQO2023-06-06
10801902192254ARROWTELEFLEX INCORPORATEDDQO2022-11-29
10801902192285ARROWTELEFLEX INCORPORATEDDQO2022-11-08
00763000541194RistTMMicro Therapeutics, Inc.DQO2022-05-01
00763000541200RistTMMicro Therapeutics, Inc.DQO2022-05-01
00763000541217RistTMMicro Therapeutics, Inc.DQO2022-05-01
07290017268347SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268354SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
07290017268378SeQureACCURATE MEDICAL THERAPEUTICS LTDDQO2021-07-22
00763000413767Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413774Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413781Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413798Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413804Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413811Rist™Micro Therapeutics, Inc.DQO2020-10-05
00763000413828Rist™Micro Therapeutics, Inc.DQO2020-10-05
10841156105860GREBSETTELEFLEX INCORPORATEDDQO2020-01-27