FDA.reportPublic FDA data

Indigo System

Primary DI
00814548016221
Brand
Indigo System
Company
PENUMBRA, INC.
Model
IST3-A
Device description
Indigo 110 Asp Tubing CE
Published
2016-07-30
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
K142870000
K160533000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K142870000Penumbra Embolectomy Aspiration System [INDIGO Aspiration System]Penumbra, Inc.2015-05-26QEW
K160533000Penumbra Embolectomy Aspiration System (INDIGOTM Aspiration System)Penumbra, Inc.2016-05-24QEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00814548016221PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00814548016221008145480162218145480162210814548016221

GMDN Terms#

Term, Definition table
TermDefinition
Surgical irrigation/aspiration systemAn assembly of devices used to intermittently or continuously irrigate and/or aspirate body cavities and wounds during a general surgical procedure. It provides for the removal of loose tissue, fluids, and other debris to keep the surgical site clear, helping to optimize visualization and access. The assembly typically includes a mains electricity (AC-powered) pump, collection bottles, tubing, and connectors. It may be used together with an irrigation catheter. It is not intended to be used for the administration of parenteral fluids, infusion of drugs, or for any life sustaining purposes.

Sterilization Methods#

Method table
Method

Regulatory Flags#

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

Other Devices From This Company#

Primary DI, Brand, Model table
Primary DIBrandModelCatalogPublished
00814548014258Smart Coil400SMTSTD13452016-07-30
00814548014265Smart Coil400SMTSTD13602016-07-30
00814548014272Smart Coil400SMTSTD14452016-07-30
00814548014289Smart Coil400SMTSTD14602016-07-30
00814548014296Smart Coil400SMTSTD15452016-07-30
00814548014302Smart Coil400SMTSTD15602016-07-30
00814548014319Smart Coil400SMTSTD16452016-07-30
00814548014326Smart Coil400SMTSTD16602016-07-30
00814548014333Smart Coil400SMTSTD18452016-07-30
00814548014340Smart Coil400SMTSTD18602016-07-30
00814548014357Smart Coil400SMTSTD09202016-07-30
00814548014364Smart Coil400SMTSTD09302016-07-30
00814548014395Smart Coil400SMTSTD10302016-07-30
00814548014401Smart Coil400SMTSTD10452016-07-30
00814548014418Smart Coil400SMTSTD11452016-07-30
00814548014425Smart Coil400SMTSTD11602016-07-30
00814548014432Smart Coil400SMTSTD12452016-07-30
00814548014449Smart Coil400SMTSTD12602016-07-30
00814548014463Smart Coil400SMTSTD11352016-07-30
00814548014470Smart Coil400SMTSTD12352016-07-30

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