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
00884450589977SplashWire™Merit Medical Systems, Inc.DQX2026-06-02
05415067055811EnSite™ST. JUDE MEDICAL, INC.DQK2026-06-01
00885403524618TruWave, VAMP PlusBecton, Dickinson And CompanyDXO2026-05-30
00885403524717TruWave, VAMP PlusBecton, Dickinson And CompanyDXO2026-05-30
00885403524779TruWave, VAMP PlusBecton, Dickinson And CompanyDXO2026-05-30
00885403524809TruWave, VAMP PlusBecton, Dickinson And CompanyDXO2026-05-30
00885403524847TruWave, VAMP PlusBecton, Dickinson And CompanyDXO2026-05-30
00885403524946TruWaveBecton, Dickinson And CompanyDXO2026-05-30
00885403525462TruWaveBecton, Dickinson And CompanyDXO2026-05-30
00885403525486TruWaveBecton, Dickinson And CompanyDXO2026-05-30
00885403527411TruWaveBecton, Dickinson And CompanyDXO2026-05-30
07649989542021SmartGUIDE deflectable hydrophilic guidewire Artiria Medical SADQX2026-03-02
07640142811305Guidewire 0.025 6/270cm angled Straub Medical AGDQX2022-06-30
07640142811312SET Aspirex™ S 6F 110cmStraub Medical AGDQX2022-06-30
07640142811329SET Aspirex™ S 6F 135cmStraub Medical AGDQX2022-06-30
07640142811336SET Aspirex™ S 8F 85cmStraub Medical AGDQX2022-06-30
07640142811343SET Aspirex™ S 8F 110cmStraub Medical AGDQX2022-06-30
07640142811350SET Aspirex™ S 10F 110cmStraub Medical AGDQX2022-06-30
07640142811855SET Rotarex™S 6 F x 110 cmStraub Medical AGDQX2022-05-04
07640142811862SET Rotarex™S 6 F x 135 cm Straub Medical AGDQX2022-05-04
07640142811879SET Rotarex™S 8 F x 85 cm Straub Medical AGDQX2022-05-04
07640142811886SET Rotarex™S 8 F x 110 cmStraub Medical AGDQX2022-05-04
10193489078022NAMICMEDLINE INDUSTRIES, INC.DQX2022-02-24
30193489067044NAMICMEDLINE INDUSTRIES, INC.DQX2021-06-03
07613327508499Synchro SELECTStryker CorporationDQX2020-10-20
07613327508512Synchro SELECTStryker CorporationDQX2020-10-20
07613327508529Synchro SELECTStryker CorporationDQX2020-10-20
07613327508581Synchro SELECTStryker CorporationDQX2020-10-20
07613327508628Synchro SELECTStryker CorporationDQX2020-10-20
07613327508635Synchro SELECTStryker CorporationDQX2020-10-20