FDA.reportPublic FDA data

AcQMap

Primary DI
00857042007029
Brand
AcQMap
Company
ACUTUS MEDICAL, INC.
Model
900003
Catalog number
900003
Device description
AcQMap® 3D Imaging & Mapping Catheter
Published
2018-02-15
Public version status
Update
Distribution status
Not in Commercial Distribution
MRI safety
MR Unsafe
Rx
true
Sterile
true
Single use
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
MTDCatheter,Intracardiac Mapping,High-Density Array

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
MTDCatheter, Intracardiac Mapping, High-Density ArrayCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K170819000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K170819000AcQMap 3D Imaging and Mapping CatheterAcutus Medical, Inc.2017-10-16MTD

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00857042007029PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00857042007029008570420070298570420070290857042007029

GMDN Terms#

Term, Definition table
TermDefinition
Cardiac mapping/ultrasound imaging catheterA sterile, flexible, dual-purpose tube containing an arrangement of electrodes and ultrasonic imaging transducers at its distal tip, designed for: 1) electrophysiological diagnostic examinations such as electrophysiology (EP) mapping, sensing, and recording of cardiac structures; and 2) intracardiac ultrasound for visualization of the cardiac anatomy (inner surface), primarily to support the EP functions. It is introduced percutaneously through a compatible steerable guide catheter (not included) to enable manoeuvring within the cardiac anatomy. This is a single-use device.

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
(442) 232-6100product.complaints@acutus.com

Regulatory Flags#

DUNS number
844418199
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850027837253DiamondTemp Generator Adapter8007278007272022-10-24
00850027837666AcQGuide MAX900200-003900200-0032023-08-30
00850027837635DiamondTemp Generator Adapter8008188008182022-10-24
00850027837642StabilICE9002219002212022-04-01
00850027837659StabilICE9002189002182022-04-01
00850027837192AcQMap8006988006982022-02-01
00850027837222AcQMap8006958006952022-02-01
00850027837239AcQMap8006968006962022-02-01
00850027837246AcQMap8006978006972022-02-01
00850027837444AcQMap8007108007102022-02-01
00850027837451AcQMap8007398007392022-02-01
00850027837468AcQMap8007428007422022-02-01
00850027837475AcQMap8007458007452022-02-01
00850027837482AcQMap8007488007482022-02-01
00857042007333AcQMap8006018006012022-02-01
00857042007357AcQMap8002558002552022-02-01
00857042007364AcQMap8004058004052022-02-01
00857042007388AcQMap8005318005312022-02-01
00857042007425AcQMap8006048006042022-02-01
00857042007999AcQMap9000009000002022-02-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850064686166OptiMap Catheter - 60mmCortex, Inc.MTD2026-05-15
00850064686159OptiMap Catheter - 50mmCortex, Inc.MTD2026-04-02
00850064686067OptiMap™ Catheter - 50mmCortex, Inc.MTD2025-07-24
00850064686074OptiMap™ Catheter - 60mmCortex, Inc.MTD2025-07-10
05415067049889Advisor™ HD Grid X, Sensor Enabled™ST. JUDE MEDICAL, INC.MTD2024-08-23
00841824105560ECOIIW.H.P.M. INC.MTD2024-08-22
00860457001544Ablacon™ Mapping CatheterAblacon Inc.MTD2023-12-07
00860457001551Ablacon™ Mapping CatheterAblacon Inc.MTD2023-12-07
10846835025811OPTRELL Mapping Catheter with TRUEref TechnologyBiosense Webster IncMTD2023-10-04
10846835025828OPTRELL Mapping Catheter with TRUEref TechnologyBiosense Webster IncMTD2023-10-04
10846835021110OCTARAY Mapping CatheterBiosense Webster IncMTD2021-10-14
10846835021127OCTARAY Mapping CatheterBiosense Webster IncMTD2021-10-14
10846835021134OCTARAY Mapping CatheterBiosense Webster IncMTD2021-10-14
10846835021141OCTARAY Mapping CatheterBiosense Webster IncMTD2021-10-14
10846835021158OCTARAY Mapping CatheterBiosense Webster IncMTD2021-10-14
10846835021233OCTARAY Mapping CatheterBiosense Webster IncMTD2021-10-14
10888551045179NASTERILMED, INC.MTD2021-10-12
10888551045186NASTERILMED, INC.MTD2021-10-12
10888551045193NASTERILMED, INC.MTD2021-10-12
10888551045209NASTERILMED, INC.MTD2021-10-12
00857042007401AcQMapACUTUS MEDICAL, INC.MTD2021-10-08
00857042007418AcQMapACUTUS MEDICAL, INC.MTD2021-10-08
10846835022056CARTO 3 System eco Interface CableBiosense Webster IncMTD2021-07-30
05415067028198Advisor™ HD Grid, Sensor Enabled™ST. JUDE MEDICAL, INC.MTD2018-05-01
08714729780434Constellation®BOSTON SCIENTIFIC CORPORATIONMTD2016-09-24
08714729780441Constellation®BOSTON SCIENTIFIC CORPORATIONMTD2016-09-24
08714729780458Constellation®BOSTON SCIENTIFIC CORPORATIONMTD2016-09-24
08714729780465Constellation®BOSTON SCIENTIFIC CORPORATIONMTD2016-09-24
08714729780472Constellation®BOSTON SCIENTIFIC CORPORATIONMTD2016-09-24
10846835009576PENTARAY NAVBiosense Webster IncMTD2016-09-16