FDA.reportPublic FDA data

Hemostasis Adapter

Primary DI
M58800100111411
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
Update
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
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.

Regulatory Flags#

DUNS number
024942265
Device count
5
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
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
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
M58800100246910V-Sono Intracardiac Echo Manipulator1001-002469-12016-05-02
M58800100411590Cardiodrive SystemII001-004115-92016-08-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00884450589977SplashWire™Merit Medical Systems, Inc.DQX2026-06-02
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
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07613327508635Synchro SELECTStryker CorporationDQX2020-10-20
07640142810575SET Rotarex®S 6F 110cm (Straub Medical®)Straub Medical AGDQX2020-01-31
07640142810582SET Rotarex®S 6F 135cm (Straub Medical®)Straub Medical AGDQX2020-01-31
07640142810599SET Rotarex®S 8F 85cm (Straub Medical®)Straub Medical AGDQX2020-01-31
07640142810605SET Rotarex®S 8F 110 cm (Straub Medical®)Straub Medical AGDQX2020-01-31
07613327459647Synchro2Stryker CorporationDQX2019-06-20
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08498840011898VYGONVygon CorporationDQX2019-04-08
08498840011911VYGONVygon CorporationDQX2019-04-08