FDA.reportPublic FDA data

Ikon 14 Guidewire

Primary DI
00812212030801
Brand
Ikon 14 Guidewire
Company
IMPERATIVE CARE, INC.
Model
ICGW014300S
Catalog number
ICGW014300S
Device description
"Imperative Care Neurovascular Guidewire-Standard, 0.014"", 300cm "
Published
2025-11-24
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DQXWire, Guide, Catheter
MOFGuide, Wire, Catheter, Neurovasculature

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2
MOFGuide, Wire, Catheter, NeurovasculatureCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K244061000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K244061000X-Wire GuidewireImperative Care, Inc.2025-08-26MOF

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00812212030801PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00812212030801008122120308018122120308010812212030801

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac/peripheral vascular guidewire, single-useA long, thin, sterile wire intended to be percutaneously placed into the cardiac vasculature (ventricles or coronary vessels) to function as a guide for the introduction, positioning, and/or operation of a device (e.g., catheter, pacing lead); it may also be used in the peripheral vasculature. It may be made of metal (e.g., stainless steel, Nitinol), or polymer and/or glass materials to provide MRI-compatibility, with or without coating, and is available in a variety of distal tip designs. It is used for various diagnostic and interventional procedures, and may include devices used to facilitate manipulation (e.g., torque device). This is a single-use device.

Device Sizes#

Type, Value, Unit table
TypeValueUnit
Guidewire Length300Centimeter
Outer Diameter0.014Inch

Storage And Handling#

Type, Low, High table
TypeLowHighCondition
Special Storage Condition, Specify00Store in a cool, dry place at room temperature. Avoid exposure to water, sunlight, extreme temperatures and high humidity during storage.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
1-408-502-7548CustomerService@Imperativecare.com

Regulatory Flags#

DUNS number
080816678
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00812212030764Zoom 4S CatheterICRC04S160ICRC04S1602025-11-24
00812212030771Zoom 4S CatheterICRC04S144ICRC04S1442025-11-24
00812212030788Zoom 4S CatheterICRC04S125ICRC04S1252025-11-24
00812212030795Ikon 14 GuidewireICGW014200SICGW014200S2025-11-24
00812212030818Ikon 14 Pro GuidewireICGW014200PICGW014200P2025-11-24
00812212030825Ikon 14 Pro GuidewireICGW014300PICGW014300P2025-11-24
00812212030832Ikon 18 GuidewireICGW018200SICGW018200S2025-11-24
00812212030856Ikon 18 Pro GuidewireICGW018200PICGW018200P2025-11-24
00812212030863Ikon 18 Pro GuidewireICGW018260PICGW018260P2025-11-24
00812212030887Ikon 24 GuidewireICGW024200SICGW024200S2025-11-24
00812212030900Ikon 24 Pro GuidewireICGW024200PICGW024200P2025-11-24
00812212030474Zoom CatheterICRC055137ICRC0551372022-07-08
00812212030498Zoom CatheterICRC045144ICRC0451442022-07-08
00812212030443Zoom CatheterICRC035158ICRC0351582021-11-17
00812212030450Zoom CatheterICRC071137ICRC0711372021-10-18
00812212030337TracStar LDP Large Distal PlatformICAC088095ICAC0880952021-09-22
00812212030344TracStar LDP Large Distal PlatformICAC088105ICAC0881052021-09-22
00850032079167Symphony™ Clot ContainerSYMPHONYCCSYMPHONYCC2024-02-02
00850032079211Symphony™ 16F 82cm CatheterSYMPHONY16F 82SYMPHONY16F822024-08-09
00850032079174Symphony™ Advance™ Long DilatorADVANCEADVANCE2024-03-04

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Primary DI, Brand, Company table
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04547327167253CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
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10801902198461ARROWTELEFLEX INCORPORATEDDQX2026-07-30
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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
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