FDA.reportPublic FDA data

ZIPwire™

Primary DI
08714729764137
Brand
ZIPwire™
Company
Lake Region Medical
Model
M00146315B0
Catalog number
M00146315B0
Published
2016-11-02
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
DQXWire, Guide, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K000011000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K000011000MODIFIED HYDROPHILIC COATED GUIDEWIRELake Region Mfg., Inc.2000-03-01DQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
08714729754923PackageGS15In Commercial Distribution
08714729764137PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, EAN-13 table
Source identifierGTIN-14 normalizedEAN-13
08714729754923087147297549238714729754923
08714729764137087147297641378714729764137

GMDN Terms#

Term, Definition table
TermDefinition
Peripheral vascular guidewire, manualA long, thin wire intended to be percutaneously placed into the peripheral vasculature (not heart or central nervous system) to function as a guide for the introduction of devices (e.g., catheters). It is made of metal (e.g., stainless steel, Nitinol), with or without coating, and is available in a variety of distal tip designs. It is intended to be used for percutaneous angiography, angioplasty, rotational atherectomy and thrombectomy, drainage, and other diagnostic and interventional procedures. It may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Length180Centimeter
Outer Diameter0.038Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry, dark place.

Regulatory Flags#

DUNS number
031108704
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
00816349012570Safari2H74939661L12026-06-25
00816349012587Safari2H74939661S12026-06-25
00816349012594Safari2H74939661XS12026-06-25
00816349013676WallStentMDTBG-023V2026-06-25
00816349015755IntuitionABFBF-011VIN32180J12026-05-12
00816349013539GuideRight404569-1404569-12026-03-24
00816349013546GuideRight404570-1404570-12026-03-24
00816349013553GuideRight404578-1404578-12026-03-24
00816349013560GuideRight404571-1404571-12026-03-24
00816349013577GuideRight404577-1404577-12026-03-24
00816349013584GuideRight404610-1404610-12026-03-24
00816349013591GuideRight404617-1404617-12026-03-24
00816349013607GuideRight404840-1404840-12026-03-24
00816349013614GuideRight404843-1404843-12026-03-24
00816349013621GuideRight404844-1404844-12026-03-24
00816349013638GuideRight404878-1404878-12026-03-24
00816349013645GuideRight404568-1404568-12026-03-24
00816349013652GuideRight404555-1404555-12026-03-24
00816349013669GuideRight404560-1404560-12026-03-24
10816349013536GuideRight404569-1404569-12026-03-24

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
10801902206241ARROWTELEFLEX INCORPORATEDDQX2026-08-03
10801902192230ARROWTELEFLEX INCORPORATEDDQX2026-08-01
04547327167215CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167222CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167239CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167246CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167253CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167260CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
10801902190908ARROWTELEFLEX INCORPORATEDDQX2026-07-30
10801902198461ARROWTELEFLEX INCORPORATEDDQX2026-07-30
10705032057004AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057011AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057028AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057035AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057042AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057059AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057066AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057073AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057080AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10801902193237ARROWTELEFLEX INCORPORATEDDQX2026-07-29
10801902193244ARROWTELEFLEX INCORPORATEDDQX2026-07-29
10801902195101ARROWTELEFLEX INCORPORATEDDQX2026-07-29
10801902193251ARROWTELEFLEX INCORPORATEDDQX2026-07-27
10801902193268ARROWTELEFLEX INCORPORATEDDQX2026-07-27
10801902193275ARROWTELEFLEX INCORPORATEDDQX2026-07-27
10801902222357ARROWTELEFLEX INCORPORATEDDQX2026-07-27
04260461060036EMERYGLIDENano4Imaging GmbHDQX2026-07-23
07290015107426Drivewire 35 GuidewireRAPID MEDICAL LTDDQX2026-07-20
06936733736951ULTRASKINLepu Medical Technology (Beijing) Co.,Ltd.DQX2026-07-10
00884450529348SplashWire™Merit Medical Systems, Inc.DQX2026-07-07