FDA.report

Volta AF-Xplorer II

Primary DI
03770019196069
Company
SUBSTRATE HD
Model
A003
Catalog number
A003
Device description
Cardiac Electrophysiology mapping tool
Published
2025-11-18
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

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

Identifiers

IdentifierTypeAgencyPackage quantityStatus
03770019196069PrimaryGS10

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityPackage typeContains DIDiscontinue dateStatus
03770019196069PrimaryGS10

Product Codes

CodeNameClassSpecialtyRegulationImplantMalfunction reporting
DQKComputer, Diagnostic, Programmable2Cardiovascular870.1425NEligible

Premarket Submissions

SubmissionSupplement
K251518000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K251518000Volta AF-Xplorer IIVolta Medical2025-09-12DQK

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).

Device Sizes

No records found.

Storage And Handling

No records found.

Sterilization Methods

Method

Contacts

No records found.

Other Devices From This Company

Primary DIBrandModelCatalogPublished
03770019196038Volta AF-XplorerA002A0022023-03-09
03770019196007VX1A001A0012021-06-15

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
00763000998394N/AMEDTRONIC, INC.DQK2025-11-14
05415067051158EnSite™ST. JUDE MEDICAL, INC.DQK2025-09-15
05415067051172EnSite™ST. JUDE MEDICAL, INC.DQK2025-09-15
07540162100246Globe Positioning System (GPS™) CableKardium IncDQK2025-09-15