FuStarTM Steerable introducer

Primary DI
06938370117841
Brand
FuStarTM Steerable introducer
Company
Lifetech Scientific (Shenzhen) Co., Ltd.
Model
SVB7F-900
Device description
The FuStarTM Steerable Introducers are designed to perform as a guiding shealth and/or introducer sheath, which provides a pathway through whichdevices are introduced within the chambers and coronary vasculature of the heart or in the peripheral vasculature. Its low- profile design and atraumatic tip reduce the potential risk for trauma during percutaneous punctures while facilitating passage of a wide variety of cathelters and devices.The proposed introducer can give physicians good control during operation, the curl options are available at 30mm (Small) and 50mm(Large). Ineach option, there are 2 connector types which are luer lock connector and silicone valve connector, and several specifications combination Also, the visible knob with scale of controller facillitates the physicians to estimate the deflecting angle of the sheath while intra-operation.The products are available in different effective length (550mm, 700mm and 900mm) and diameter (French sie, 5F, 6F, 7F, 8F, 9F and 10F). The deflection angle of shealth is from 0 degree to 180 degree.
Published
2017-11-14
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
DQYCatheter, Percutaneous

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQYCatheter, PercutaneousCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K100184000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K100184000FUSTAR STEERABLE INTRODUCERSLifetech Scientific (Shenzhen) Co., Ltd.2011-02-14DQY

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06938370117841PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06938370117841069383701178416938370117841

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac occluder delivery kitA collection of sterile devices designed to implant a cardiac occluder for the non-surgical closure of cardiac defects. The collection may include a delivery catheter/sheath, dilator, loading device, delivery cable, and additional items for the intravascular delivery and deployment of a cardiac occlude; the cardiac occluder is not included. The devices are used in the treatment of cardiac disorders that may include (but not limited to) atrial septal defects (ASD), ventricular septal defects (VSD), patent foramen ovale (PFO), or patent ductus arteriosus (PDA). This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
529864170
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
06938370118015SeQureTM Snare SystemLT-SG-052017-11-17
06938370118022SeQureTM Snare SystemLT-SG-102017-11-17
06938370118039SeQureTM Snare SystemLT-SG-152017-11-17
06938370118046SeQureTM Snare SystemLT-SG-202017-11-17
06938370118053SeQureTM Snare SystemLT-SG-252017-11-17
06938370118060SeQureTM Snare SystemLT-SG-302017-11-17
06938370118077SeQureTM Snare SystemLT-SG-352017-11-17
06938370118084SeQureTM Snare SystemLT-SP-102017-11-17
06938370118091SeQureTM Snare SystemLT-SP-252017-11-17
06938370118107SeQureTM Snare SystemLT-SM-022017-11-17
06938370118114SeQureTM Snare SystemLT-SM-042017-11-17
06938370118121SeQureTM Snare SystemLT-SM-072017-11-17
06938370117049FuStarTM Steerable introducerSLA5F-5502017-11-03
06938370117056FuStarTM Steerable introducerSLA5F-7002017-11-03
06938370117063FuStarTM Steerable introducerSLA5F-9002017-11-03
06938370117070FuStarTM Steerable introducerSLA6F-5502017-11-06
06938370117087FuStarTM Steerable introducerSLA6F-7002017-11-06
06938370117094FuStarTM Steerable introducerSLA6F-9002017-11-06
06938370117100FuStarTM Steerable introducerSLA7F-5502017-11-06
06938370117117FuStarTM Steerable introducerSLA7F-7002017-11-06

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