FDA.reportPublic FDA data

Helo G1 Thrombectomy System

Primary DI
00850044140008
Brand
Helo G1 Thrombectomy System
Company
Endovascular Engineering, Inc.
Model
20001
Published
2026-04-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
KRACatheter, Continuous Flush

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
KRACatheter, Continuous FlushCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K223891000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K223891000Cobra Catheter SystemEndovascular Engineering2023-02-15QEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00850044140008PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00850044140008008500441400088500441400080850044140008

GMDN Terms#

Term, Definition table
TermDefinition
Thrombectomy suction catheterA flexible or semi-flexible tube designed for the percutaneous, transluminal disruption and removal of clotted blood (i.e., a thrombus or thromboembolus) or other formed elements causing vascular obstruction in native/stented blood vessels, native/synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) in conjunction with a syringe or dedicated suction pump system (pump not included). It may additionally be intended for infusion of fluids and/or used as a guide-catheter to facilitate introduction of a thrombectomy wire-net (not included) to remove residual thrombus. Collection containers may be included with the catheter. This is a single-use device.

Regulatory Flags#

DUNS number
117560059
Device count
1
Lot or batch
true
Expiration date on label
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00850044140015Helo Thrombectomy SystemHEL15952026-03-13

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885403542667TRUWAVEBecton, Dickinson And CompanyKRA2026-09-05
00885403530534FogartyBecton, Dickinson And CompanyKRA2026-08-14
00885403530541FogartyBecton, Dickinson And CompanyKRA2026-08-14
00885403530558FogartyBecton, Dickinson And CompanyKRA2026-08-14
00885403530572FogartyBecton, Dickinson And CompanyKRA2026-08-14
00885403530589FOGARTYBecton, Dickinson And CompanyKRA2026-08-14
00885403523581VAMPBecton, Dickinson And CompanyKRA2026-07-31
00885403523598VAMPBecton, Dickinson And CompanyKRA2026-07-31
00885403523734VAMPBecton, Dickinson And CompanyKRA2026-07-31
00885403530565FogartyBecton, Dickinson And CompanyKRA2026-07-31
00885403542766TruWave, VAMP PlusBecton, Dickinson And CompanyKRA2026-07-31
00885403522331Swan-GanzBecton, Dickinson And CompanyKRA2026-07-24
00884450825969Fountain®Merit Medical Systems, Inc.KRA2026-06-24
00884450826560Fountain®Merit Medical Systems, Inc.KRA2026-06-09
00850013694099MicroGuideMicro Medical Solutions, Inc.KRA2026-04-24
00690103218602SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCKRA2026-03-16
00690103218626SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCKRA2026-03-16
00690103218633SWAN-GANZ TRUE SIZEEdwards Lifesciences LLCKRA2026-03-16
00810123710522Triever20 CurveInari Medical, Inc.KRA2023-12-15
00812339030319Pounce Venous Thrombectomy SystemSurmodics, Inc.KRA2023-10-27
00850291007277ClotTriever XL CatheterInari Medical, Inc.KRA2023-05-09
00850291007376Artix™ AXInari Medical, Inc.KRA2023-04-24
00812339030302Pounce™ Venous Thrombectomy SystemSurmodics, Inc.KRA2022-06-22
07640132622690M-CATH FlexyAcrostak (Schweiz) AGKRA2021-11-01
07640132622706M-CATH FlexyAcrostak (Schweiz) AGKRA2021-11-01
00763000399641PhenomTM 17 CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000399658PhenomTM 17 CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000399665PhenomTM 17 CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000399672PhenomTM 17 CatheterMicro Therapeutics, Inc.KRA2021-04-26
00763000399689PhenomTM 21 CatheterMicro Therapeutics, Inc.KRA2021-04-26