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Acutus Medical Inc

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30121207463012120746Acutus Medical Inc1N2020-04-252210 Faraday Ave Ste 100 Carlsbad CA US 92008

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
00857042007067AcQMap - AcQMap® Ablation Interface Unit(442) 232-6100product.complaints@acutus.com
00857042007074AcQMap - Ampere® Adapter CableAcQMap® Ablation Catheter(442) 232-6100product.complaints@acutus.com

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1874021797004127K190131AcQMap High Resolution Imaging and Mapping SystemDQK2019-04-02
1874021388333645K171557AcQRef Introducer SheathDYB2018-02-06
1874021933952607K171081Guider Catheter IntroducerDYB2017-05-09
1874021017020390K170948AcQMap High Resolution Imaging and Mapping SystemDQK2017-10-16
1874021097704376K170819AcQMap 3D Imaging and Mapping CatheterMTD2017-10-16
1874021617313567K170373Flextra Steerable IntroducerDYB2017-02-27
1874021893186367K162925AcQGuide Steerable SheathDRA2017-04-06

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
DYB32018-02-06
DQK22019-04-02
MTD12017-10-16
DRA12017-04-06

PMN#

GUDID#

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