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
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
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
10850022994002PackageGS15In Commercial Distribution
00850022994005PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
1085002299400210850022994002
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.

Regulatory Flags#

DUNS number
080001248
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
false
Sterilization required before use
false

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
00195278840202MACGe Medical Systems Information Technologies, Inc.DQK2026-10-13
30801902124921ARROWTELEFLEX INCORPORATEDDQX2026-10-13
10884450356408Safedraw™ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DSK2026-10-07
10884450372965Safedraw™ARGON CRITICAL CARE SYSTEMS SINGAPORE PTE. LTD.DSK2026-10-07
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyDQK2026-10-04
00195278949752TruSignal SpO2 MM 3.0MGE Healthcare Finland OyDSK2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDQK2026-10-04
00195278949769TruSignal SpO2 MM 1.8MGE Healthcare Finland OyDSK2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyDQK2026-10-04
00198953002186Carescape Dock F0GE Healthcare Finland OyDSK2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyDSK2026-10-04
00198953009567Carescape ONEGE Healthcare Finland OyDQK2026-10-04
07540184010127OptoMonitorOpsens IncDXO2026-09-30
07540184010127OptoMonitorOpsens IncDQX2026-09-30
07540184020027OptoMonitorOpsens IncDXO2026-09-30
07540184020027OptoMonitorOpsens IncDQX2026-09-30
07540184020034OptoMOnitorOpsens IncDXO2026-09-30
07540184020034OptoMOnitorOpsens IncDQX2026-09-30
07540184020041OptoMonitorOpsens IncDQX2026-09-30
07540184020041OptoMonitorOpsens IncDXO2026-09-30
07540184020058OptoMonitorOpsens IncDQX2026-09-30
07540184020058OptoMonitorOpsens IncDXO2026-09-30
07540184020065OptoMonitorOpsens IncDQX2026-09-30
07540184020065OptoMonitorOpsens IncDXO2026-09-30
07540184020072OptoMonitorOpsens IncDQX2026-09-30
07540184020072OptoMonitorOpsens IncDXO2026-09-30
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