FDA.reportPublic FDA data

LawMax Dilator

Primary DI
06938370131557
Brand
LawMax Dilator
Company
Lifetech Scientific (Shenzhen) Co., Ltd.
Model
LT-DIL-22F
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
DREDilator, Vessel, For Percutaneous Catheterization

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DREDilator, Vessel, For Percutaneous CatheterizationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K123842000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K123842000LAWMAX DILATORLifetech Scientific (Shenzhen) Co., Ltd.2013-06-24DRE

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
06938370131557PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
06938370131557069383701315576938370131557

GMDN Terms#

Term, Definition table
TermDefinition
Vascular dilator, single-useA sterile, hand-held, surgical instrument designed for insertion into a blood vessel (the vasculature) to unblock, enlarge or measure the internal diameter of the vessel during a surgical intervention. It is a rod-like device with a long, slender, body that terminates with a bulbous, cylindrical distal tip of various shapes and sizes. Commonly known as a vessel dilator or vascular probe, it is available in a variety of sizes (diameters and lengths) and flexibilities. It is typically made of metal or plastic materials. 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

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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00884450838211Prelude Roadster™Merit Medical Systems, Inc.DRE2026-08-18
00884450838136Prelude Roadster™Merit Medical Systems, Inc.DRE2026-07-31
10884450708955Prelude®Merit Medical Systems, Inc.DRE2026-07-18
10884450415631Prelude®Merit Medical Systems, Inc.DRE2026-07-08
10884450415655Prelude®Merit Medical Systems, Inc.DRE2026-07-08
10884450707781Prelude®Merit Medical Systems, Inc.DRE2026-07-08
00884450860342Merit S-MAK™Merit Medical Systems, Inc.DRE2026-06-25
00884450468340Merit MAK™Merit Medical Systems, Inc.DRE2026-06-23
10884450706708Prelude®Merit Medical Systems, Inc.DRE2026-06-03
10884450415358Prelude®Merit Medical Systems, Inc.DRE2026-05-28
00685447020264VersaCross Connect™ Transseptal DilatorBOSTON SCIENTIFIC CORPORATIONDRE2025-02-25
00685447020271VersaCross Connect™ Transseptal DilatorBOSTON SCIENTIFIC CORPORATIONDRE2025-02-25
00685447020288VersaCross™ Large Access Trasseptal DilatorBOSTON SCIENTIFIC CORPORATIONDRE2025-02-25
00685447020295VersaCross™ Large Access Trasseptal DilatorBOSTON SCIENTIFIC CORPORATIONDRE2025-02-25
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