FDA.reportPublic FDA data

Hemostasis Adapter

Primary DI
M58800100111410
Brand
Hemostasis Adapter
Company
STEREOTAXIS, INC.
Model
IV-1
Catalog number
0010011141
Device description
Hemostasis Adapter IV Spares, Box, Device Count(5)
Published
2021-12-14
Public version status
New
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
DQXWire, Guide, Catheter

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DQXWire, Guide, CatheterCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K071029000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K071029000CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS)Stereotaxis, Inc.2007-08-24DQX

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
M58800100111411PrimaryHIBCC0
M58800100111410Unit of UseHIBCC0

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac mapping system workstationA mains electricity (AC-powered) device designed as a control unit to percutaneously navigate (orientate and steer) a cardiac mapping system catheter, or its associated guidewire, in the desired direction to the designated target site (e.g., coronary vasculature). It uses dedicated software and may employ various technologies (often magnetic fields); it is typically used in the electrophysiology (EP) laboratory.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
024942265
Device count
5
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
M588020004500380Navigant5.2020-004500-382026-07-03
M58800100620010Niobe MNS OmegaES Omega001-006200-12026-04-23
M58800101400010GenesisX100101400012026-01-09
M588001004115110Cardiodrive SystemII001-004115-112022-06-06
M588001004115120Cardiodrive SystemII001-004115-122022-06-06
M58800101100010Genesis (RMNS) 1.1001-011000-12020-08-20
M58800101100030Genesis MNS with Model-S1.1 Model-S001-011000-32020-08-20
M588020004500210Navigant4.6.4020-004500-212016-08-01
M588020004500220Navigant4.6.5020-004500-222016-08-01
M588020004500260Navigant5.0.2020-004500-262016-10-27
M58800100701020OdysseyQuad HD001-007010-22016-08-01
M58800100111411Hemostasis AdapterIV-100100111412021-12-14
M58802000780030Cinema MAS & MMSDMS-100020-007800-32016-08-01
M58800100175110QuikCAS Cardiodrive Sterile Components1001-001751-12016-05-02
M5880010017711QuikCAS Hemostasis Adapter1001-001771-12016-08-01
M5880010017712Cardiodrive Hemostasis Adapter - SJ1001-001771-22016-08-01
M58800100230710Vdrive SystemSingle Arm001-002307-12016-08-01
M58800100230720Vdrive SystemDuo001-002307-22016-08-01
M58800100242210V-CAS Catheter Advancement System1001-002422-12016-05-02
M58800100245210V-Loop Variable Loop Catheter Manipulator1001-002452-12016-05-02

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450529300SplashWire™Merit Medical Systems, Inc.DQX2026-08-21
00884450529713SplashWire™Merit Medical Systems, Inc.DQX2026-08-21
00884450529829SplashWire™Merit Medical Systems, Inc.DQX2026-08-21
00884450590010SplashWire™Merit Medical Systems, Inc.DQX2026-08-21
00884450631928InQwire® AmplatzMerit Medical Systems, Inc.DQX2026-08-21
00884450731789InQwire®Merit Medical Systems, Inc.DQX2026-08-21
00884450739709InQwire®Merit Medical Systems, Inc.DQX2026-08-21
10801902226430ARROWTELEFLEX INCORPORATEDDQX2026-08-10
10801902206241ARROWTELEFLEX INCORPORATEDDQX2026-08-03
10801902192230ARROWTELEFLEX INCORPORATEDDQX2026-08-01
04547327167215CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167222CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167239CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167246CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167253CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
04547327167260CROSSLOOPASAHI INTECC CO., LTD.DQX2026-07-31
10801902190908ARROWTELEFLEX INCORPORATEDDQX2026-07-30
10801902198461ARROWTELEFLEX INCORPORATEDDQX2026-07-30
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10705032057028AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
10705032057035AQUATRACK™ Hydrophilic Nitinol GuidewireCordis US Corp.DQX2026-07-29
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
10801902193244ARROWTELEFLEX INCORPORATEDDQX2026-07-29
10801902195101ARROWTELEFLEX INCORPORATEDDQX2026-07-29