FDA.reportPublic FDA data

Barostim

Primary DI
00859144004630
Brand
Barostim
Company
CVRX, INC.
Model
9020
Catalog number
100067-202
Device description
Model 9020 Barostim Programmer System
Published
2026-01-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true

Contact Domains#

Product Codes#

Code, Name table
CodeName
DSRStimulator, Carotid Sinus Nerve

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DSRStimulator, Carotid Sinus NerveCardiovascular3

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
P180050002

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
P180050002BAROSTIM NEO® SystemCvrx, Inc.2019-08-16DSR

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00859144004630PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00859144004630008591440046308591440046300859144004630

Sterilization Methods#

Method table
Method

Contacts#

Phone, Email table
PhoneEmail
763-416-7457acrouse@cvrx.com

Regulatory Flags#

DUNS number
052373680
Device count
1
Serial number
true
Manufacturing date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00859144004623Barostim NEO22104100065-2022026-01-21
00859144004432BAROSTIM NEO2102100054-2022019-08-22
00859144004470BAROSTIM NEO1037100063-2222019-08-22
00859144004128NA9010100055-1022015-01-21
00859144004227NA5000100034-3012015-01-21
00859144004234NA5500100033-3012015-01-21
00859144004449BAROSTIM Programmer9010100055-2022019-08-22
00859144004456BAROSTIM Lead Repair Kit5010100056-2022019-08-22
00859144004463BAROSTIM NEO1036100063-2122019-08-22
00859144004203NA5010100056-3012015-01-21
00859144004210Neo Legacy2100100053-3012015-01-21

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00859144004623Barostim NEO2CVRX, INC.DSR2026-01-21
00859144004432BAROSTIM NEOCVRX, INC.DSR2019-08-22
00859144004449BAROSTIM ProgrammerCVRX, INC.DSR2019-08-22
00859144004456BAROSTIM Lead Repair KitCVRX, INC.DSR2019-08-22
00859144004463BAROSTIM NEOCVRX, INC.DSR2019-08-22
00859144004470BAROSTIM NEOCVRX, INC.DSR2019-08-22
00859144004128NACVRX, INC.DSR2015-01-21
00859144004203NACVRX, INC.DSR2015-01-21
00859144004210Neo LegacyCVRX, INC.DSR2015-01-21
00859144004227NACVRX, INC.DSR2015-01-21
00859144004234NACVRX, INC.DSR2015-01-21