FDA.reportPublic FDA data

Zurich Pressure Guidewire System

Primary DI
00850022994005
Brand
Zurich Pressure Guidewire System
Company
ZURICH MEDICAL INC.
Model
Model 100
Catalog number
308
Published
2020-09-21
Public version status
New
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
DQKComputer, Diagnostic, Programmable
DQXWire, Guide, Catheter
DSKComputer, Blood-Pressure
DXOTransducer, Pressure, Catheter Tip

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2
DQXWire, Guide, CatheterCardiovascular2
DSKComputer, Blood-PressureCardiovascular2
DXOTransducer, Pressure, Catheter TipCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K190852000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K190852000Zurich Pressure Guidewire System Model 100Zurich Medical, Inc.2019-08-14DXO

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850022994005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850022994005008500229940058500229940050850022994005

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.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
080001248
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850022994456Zurich Medical Accessory CableMindray 12-Pin, Type A512-1512025-11-06
00850022994463Zurich Medical Accessory CableMindray 12-Pin, Type C512-1522025-11-06
00850022994470Zurich Medical Accessory CableMindray 12-Pin, Type G512-1532025-11-06
00850022994487Zurich Medical Accessory CableMindray 12-Pin, Type I512-1542025-11-06
00850022994524Zurich Medical Accessory CableDraeger BNC, Type A512-1612025-11-03
00850022994531Zurich Medical Accessory CableDraeger BNC, Type C512-1622025-11-03
00850022994548Zurich Medical Accessory CableDraeger BNC, Type G512-1632025-11-03
00850022994555Zurich Medical Accessory CableDraeger BNC, Type I512-1642025-11-03
00850022994388Zurich Medical Accessory CableMindray 9-Pin, Type A512-0412025-09-08
00850022994395Zurich Medical Accessory CableMindray 9-Pin, Type C512-0422025-09-08
00850022994401Zurich Medical Accessory CableMindray 9-Pin, Type G512-0432025-09-08
00850022994418Zurich Medical Accessory CableMindray 9-Pin, Type I512-0442025-09-08
00850022994272Zurich Medical Accessory CableSiemens 8-Pin, Type C512-1422023-04-13
00850022994289Zurich Medical Accessory CableSiemens 8-Pin, Type G512-1432023-04-13
00850022994333Zurich Medical Accessory CableDraeger-Siemens 14-Pin, Type C512-0322023-04-13
00850022994340Zurich Medical Accessory CableDraeger-Siemens 14-Pin, Type G512-0332023-04-13
00850022994104Zurich Medical Accessory CableGE 9-Pin, Type C512-0222021-01-28
00850022994111Zurich Medical Accessory CableGE 9-Pin, Type G512-0232021-01-28
00850022994159Zurich Medical Accessory CableMerge 3.5mm, Type C512-1322021-01-28
00850022994166Zurich Medical Accessory CableMerge 3.5mm, Type G512-1332021-01-28

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00818075011261AristotleSCIENTIA VASCULAR LLCDQX2026-09-21
05415067057952EnSite™ST. JUDE MEDICAL, INC.DQK2026-09-21
05415067057969EnSite™ST. JUDE MEDICAL, INC.DQK2026-09-21
00191506063214OPAL HDx™BOSTON SCIENTIFIC CORPORATIONDQK2026-09-20
00885403523512HemoSphere AltaBecton, Dickinson And CompanyDQK2026-09-18
00885403523536HemoSphere AltaBecton, Dickinson And CompanyDQK2026-09-18
00885403533665TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403533764Smart Pressure ControllerBecton, Dickinson And CompanyDQK2026-09-18
00885403533771Smart Pressure Controller Accessory KitBecton, Dickinson And CompanyDQK2026-09-18
00885403543282TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403543299TruWaveBecton, Dickinson And CompanyDXO2026-09-18
00885403543305TruWaveBecton, Dickinson And CompanyDXO2026-09-18
00885403543312TruWaveBecton, Dickinson And CompanyDXO2026-09-18
00885403543428TruWaveBecton, Dickinson And CompanyDXO2026-09-18
00885403543435TruWaveBecton, Dickinson And CompanyDXO2026-09-18
00885403543459TruWaveBecton, Dickinson And CompanyDXO2026-09-18
00885403543466TruWaveBecton, Dickinson And CompanyDXO2026-09-18
00885403543473TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403543480TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544128TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544135TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544142TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544159TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544166TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544180TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544432TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544470TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544487TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544494TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18
00885403544500TruWave Reusable CableBecton, Dickinson And CompanyDXO2026-09-18