SeQureTM Snare System

Primary DI
06938370118121
Brand
SeQureTM Snare System
Company
Lifetech Scientific (Shenzhen) Co., Ltd.
Model
LT-SM-07
Device description
The SeQureTM Snare System consists of a snare, a catheter, a loader and a torquer. The snare is constructed of a nitinol shaft and a loop with the plane of the loop perpendicular to the nitinol shaft. The nitinol loop is covered with a tungsten coil which is coated by laminated titanium and its nitride to enhance radiopaque. The pre-formed snare loop can be introduced through catheter without risk of permanent deformiation because of super-elasticity of nitinol material. The catheter consists of luer connector and PE tubing with a radiopaque markband at its distal tip to enhance the visibility during the operation. The snare is pre-assembled with the loader and the torque, and then packaged together with corresponding catheter.
Published
2017-11-17
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
MMXDevice, Percutaneous Retrieval

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MMXDevice, Percutaneous RetrievalCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K102484000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K102484000SEQURE SNARE SYSTEMLifetech Scientific (Shenzhen) Co., Ltd.2010-11-09MMX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06938370118121PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06938370118121069383701181216938370118121

GMDN Terms#

Term, Definition table
TermDefinition
Intravascular catheter-snareA sterile, flexible, end- and/or side-hole tube with a long snaring device (e.g., a wire loop or noose) inserted through its lumen, designed to be introduced into a blood vessel or similar structure to manually retrieve or manipulate a foreign body. It is typically available in two forms: 1) the loop emerges from the distal tip of the catheter while both free ends of the wire emerge from the proximal end; and 2) the end of the wire is attached to the distal end of the catheter while the free end is passed through the lumen to emerge at the proximal end. The wire is usually made of a high-strength, stiff metal [e.g., nickel-titanium alloy (Nitinol)].

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
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
06938370117124FuStarTM Steerable introducerSLA7F-9002017-11-06

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00763000762414Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
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00763000762438Amplatz Goose Neck™MEDTRONIC, INC.MMX2024-10-27
00850041730141LimFlow V-CeiverInari Medical, Inc.MMX2024-03-09
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00850041730004LimFlow V-CeiverInari Medical, Inc.MMX2023-06-26
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00884450681763ONE Snare®Merit Medical Systems, Inc.MMX2022-12-28
10884450681760ONE Snare®Merit Medical Systems, Inc.MMX2022-12-28
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10884450681807ONE Snare®Merit Medical Systems, Inc.MMX2022-12-16