FDA.report

VX1

Primary DI
03770019196007
Brand
VX1
Company
SUBSTRATE HD
Model
A001
Catalog number
A001
Device description
Cardiac Electrophysiology mapping tool
Published
2021-06-15
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
false
Single use
false

Related Records

Product Codes

CodeName
DQKComputer, Diagnostic, Programmable

Product Code Classifications

CodeDeviceSpecialtyClass
DQKComputer, Diagnostic, ProgrammableCardiovascular2

Premarket Submissions

SubmissionSupplement
K201298000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K201298000VX1Volta Medical2020-09-16DQK

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
03770019196007PrimaryGS10

GMDN Terms

TermDefinition
Cardiac mapping system computerA dedicated computer with software that is a component of a cardiac mapping system and is used to process and store electronic information/data for the interpretation of cardiac physiological parameters received from the output of connected measuring devices [e.g., body surface or intracardiac electrocardiograph (ECG) sensors/transducers]. The measurements can be compared to pre-established diagnostic criteria for parameters such as cardiac blood flow, electrical conduction, or heart chamber geometry. The device may display real-time cardiac maps in various formats (e.g., electrical propagation maps, electrical potential maps, and cardiac chamber geometry maps).

Storage And Handling

TypeLowHighCondition
Handling Environment Atmospheric Pressure60 KiloPascal106 KiloPascal
Handling Environment Humidity10 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Handling Environment Temperature15 Degrees Celsius25 Degrees Celsius
Storage Environment Atmospheric Pressure60 KiloPascal106 KiloPascal
Storage Environment Humidity5 Percent (%) Relative Humidity95 Percent (%) Relative Humidity
Storage Environment Temperature-40 Degrees Celsius60 Degrees Celsius

Sterilization Methods

Method

Regulatory Flags

DUNS number
268244729
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
false
Combination product
false
Lot or batch
false
Serial number
true
Manufacturing date on label
true
Expiration date on label
false
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 DIBrandModelCatalogPublished
03770019196069Volta AF-Xplorer IIA003A0032025-11-18
03770019196038Volta AF-XplorerA002A0022023-03-09

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
17540262100143Change Healthcare Cardiology HemoChange Healthcare Canada CompanyDQK2026-03-09
17540262110142Change Healthcare Cardiology ECG ManagementChange Healthcare Canada CompanyDQK2026-03-09
17540262170047Change Healthcare Cardiology HemodynamicsChange Healthcare Canada CompanyDQK2026-03-09
06944413849570Holter ECG and ABP SystemEdan Instruments, Inc.DQK2026-03-02
00195278343383CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DQK2026-02-11
00195278343512CARESCAPE CENTRAL STATIONGe Medical Systems Information Technologies, Inc.DQK2026-02-11
00851424007089VIVOCatheter Precision, Inc.DQK2026-02-03
00085142400710VIVO Positioning PatchesCatheter Precision, Inc.DQK2026-02-03
00851424007119VIVO SystemCatheter Precision, Inc.DQK2026-02-03
05415067055613EnSite™ST. JUDE MEDICAL, INC.DQK2026-01-08
05415067054883EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-19
00732094360295Welch Allyn, Inc.WELCH ALLYN, INC.DQK2025-12-18
05415067053435EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-17
05415067053503EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-17
05415067053510EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-17
05415067054968EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-17
05415067054975EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-17
05415067054982EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-17
05415067054999EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-17
05415067055217EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-17
05415067055224EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-17
05415067055231EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-17
05415067055248EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-17
00850012226291iMap 3D Mapping and Navigation SystemCardionxt IncDQK2025-12-10
05415067051219EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-08
05415067051288EnSite™ST. JUDE MEDICAL, INC.DQK2025-12-08
03770019196069Volta AF-Xplorer IISUBSTRATE HDDQK2025-11-18
00763000998394N/AMEDTRONIC, INC.DQK2025-11-14
05415067051158EnSite™ST. JUDE MEDICAL, INC.DQK2025-09-15
05415067051172EnSite™ST. JUDE MEDICAL, INC.DQK2025-09-15