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

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Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
04260461060036EMERYGLIDENano4Imaging GmbHDQX2026-07-23
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17540262100150Change Healthcare Cardiology HemoChange Healthcare Canada CompanyDQK2026-07-21
17540262110166Change Healthcare Cardiology ECG ManagementChange Healthcare Canada CompanyDQK2026-07-21
17540262170054Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyDQK2026-07-21
07290015107426Drivewire 35 GuidewireRAPID MEDICAL LTDDQX2026-07-20
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