FDA.reportPublic FDA data

Indigo System

Primary DI
00814548017587
Brand
Indigo System
Company
PENUMBRA, INC.
Model
CATRXKIT160
Device description
044 Coronary Aspiration Catheter 160 cm Kit
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
00814548017587PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814548017587008145480175878145480175870814548017587

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
M4244002C03060Penumbra Coil 4004002C03062016-07-30
M4244002C03100Penumbra Coil 4004002C03102016-07-30
M4244002C04080Penumbra Coil 4004002C04082016-07-30
M4244002C04120Penumbra Coil 4004002C04122016-07-30
M4244002C05060Penumbra Coil 4004002C05062016-07-30
M4244002C05100Penumbra Coil 4004002C05102016-07-30
M4244002C06100Penumbra Coil 4004002C06102016-07-30
M4244002C06150Penumbra Coil 4004002C06152016-07-30
M4244002C07100Penumbra Coil 4004002C07102016-07-30
M4244002C07150Penumbra Coil 4004002C07152016-07-30
M4244002C07200Penumbra Coil 4004002C07202016-07-30
M4244002C08150Penumbra Coil 4004002C08152016-07-30
M4244002C08200Penumbra Coil 4004002C08202016-07-30
M4244002C08300Penumbra Coil 4004002C08302016-07-30
M4244002C09150Penumbra Coil 4004002C09152016-07-30
M4244002C09250Penumbra Coil 4004002C09252016-07-30
M4244002C09350Penumbra Coil 4004002C09352016-07-30
M4244002C10200Penumbra Coil 4004002C10202016-07-30
M4244002C10300Penumbra Coil 4004002C10302016-07-30
M4244002C10400Penumbra Coil 4004002C10402016-07-30

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
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
20801902196600ARROWTELEFLEX INCORPORATEDDXE2022-11-15
10801902194043ARROWTELEFLEX INCORPORATEDDXE2022-11-08
10801902194050ARROWTELEFLEX INCORPORATEDDXE2022-11-08
10801902194067ARROWTELEFLEX INCORPORATEDDXE2022-11-08
10801902194074ARROWTELEFLEX INCORPORATEDDXE2022-11-08
10801902194081ARROWTELEFLEX INCORPORATEDDXE2022-11-08
10801902194098ARROWTELEFLEX INCORPORATEDDXE2022-11-08
10801902194104ARROWTELEFLEX INCORPORATEDDXE2022-11-08
10801902196610ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194040ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194057ARROWTELEFLEX INCORPORATEDDXE2022-11-08
20801902194064ARROWTELEFLEX INCORPORATEDDXE2022-11-08