FDA.reportPublic FDA data

Indigo System

Primary DI
00814548017594
Brand
Indigo System
Company
PENUMBRA, INC.
Model
SEPC4
Device description
Separator 4
Published
2017-08-03
Public version status
Update
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Sterile
true
Single use
true

Product Codes#

Code, Name table
CodeName
DXECatheter, Embolectomy

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
DXECatheter, EmbolectomyCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K163618000
K220683000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K163618000INDIGO Aspiration SystemPenumbra, Inc.2017-05-24QEX
K220683000INDIGO Aspiration System (CAT RX Aspiration Catheter and Separator 4)Penumbra, Inc.2022-10-04QEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814548017594PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814548017594008145480175948145480175940814548017594

GMDN Terms#

Term, Definition table
TermDefinition
Thrombectomy suction catheterA sterile 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 and stented blood vessels, native and synthetic bypass grafts, and/or haemodialysis access grafts, through suction (aspiration) typically achieved with the use of an included syringe(s) attached to the proximal end of the catheter, or connection to a dedicated suction pump system. Collection baskets may also be included to obtain filtered blood specimens for analyses. This is a single-use device.

Sterilization Methods#

Method table
Method

Regulatory Flags#

DUNS number
191077671
Device count
1
Lot or batch
true
Expiration date on label
true
No natural rubber latex
true

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00810169720042ELEMENT Vascular Access SystemELMNT17F13-A2024-12-16
00810169720059ELEMENT Vascular Access SystemELMNT17F33-A2024-12-16
00810169720066ELEMENT Vascular Access SystemELMNT17F45-A2024-12-16
00810169720073ELEMENT Vascular Access SystemELMNT17F65-A2024-12-16
00810169720080ELEMENT Vascular Access SystemELMNT17F70-A2024-12-16
00810169720097ELEMENT Vascular Access SystemELMNT17F80-A2024-12-16
00815948028029MIDWAY43MWAY115-A2024-04-02
00815948028036MIDWAY62MWAY125-A2024-04-02
00815948028180MIDWAY43MWAY125-A2024-04-02
00815948028197MIDWAY62MWAY115-A2024-04-02
00815948026216Benchmark MAX SystemBMX96100SIM125-B2023-06-27
00815948026223Benchmark MAX SystemBMX96100MSIM125-B2023-06-27
00815948026230Benchmark MAX SystemBMX96100H1125-B2023-06-27
00815948026247Benchmark MAX SystemBMX96100MH1125-B2023-06-27
00815948026254Benchmark MAX SystemBMX96100BER125-B2023-06-27
00815948026261Benchmark MAX SystemBMX96100MBER125-B2023-06-27
00815948026278Benchmark MAX SystemBMX96100SIMV125-B2023-06-27
00815948026285Benchmark MAX SystemBMX96100MSIMV125-B2023-06-27
00815948026292Benchmark MAX SystemBMX96100-B2023-06-27
00815948026308Benchmark MAX SystemBMX9690SIM125-B2023-06-27

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00885403530534FogartyBecton, Dickinson And CompanyDXE2026-08-14
00885403530541FogartyBecton, Dickinson And CompanyDXE2026-08-14
00885403530558FogartyBecton, Dickinson And CompanyDXE2026-08-14
00885403530572FogartyBecton, Dickinson And CompanyDXE2026-08-14
00885403530589FOGARTYBecton, Dickinson And CompanyDXE2026-08-14
00885403530404FogartyBecton, Dickinson And CompanyDXE2026-07-31
00885403530411FogartyBecton, Dickinson And CompanyDXE2026-07-31
00885403530428FogartyBecton, Dickinson And CompanyDXE2026-07-31
00885403530442FogartyBecton, Dickinson And CompanyDXE2026-07-31
00885403530466FogartyBecton, Dickinson And CompanyDXE2026-07-31
00885403530565FogartyBecton, Dickinson And CompanyDXE2026-07-31
00885403530992FogartyBecton, Dickinson And CompanyDXE2026-07-31
08886483504455Embolectomy CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.DXE2026-05-04
08886483504486Embolectomy CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.DXE2026-05-04
08886483504516Embolectomy CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.DXE2026-05-04
10841156110512PRONTOTELEFLEX INCORPORATEDDXE2026-03-03
20841156110519PRONTOTELEFLEX INCORPORATEDDXE2026-03-03
00850291007697Large Bore 60 cc SyringeInari Medical, Inc.DXE2024-12-20
00763000762353Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762360Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762377Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762384Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762391Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762407Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762414Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762421Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
00763000762438Amplatz Goose Neck™MEDTRONIC, INC.DXE2024-10-27
08886483507524Embolectomy CatheterBIOPTIMAL INTERNATIONAL PTE. LTD.DXE2023-10-31
00860010378007ICHORICHOR VASCULAR, INC.DXE2023-10-13
10801902196603ARROWTELEFLEX INCORPORATEDDXE2022-11-15