FDA.reportPublic FDA data

Indigo System

Primary DI
00815948024830
Brand
Indigo System
Company
PENUMBRA, INC.
Model
LITNGFHT100H1-A
Device description
CAT16 HTORQ 100cm, Select 135cm H1 Tip, Lightning Flash Tubing
Published
2023-01-09
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
QEWPeripheral Mechanical Thrombectomy With Aspiration

Product Code Classifications#

Code, Device, Specialty table
CodeDeviceSpecialtyClass
QEWPeripheral Mechanical Thrombectomy With AspirationCardiovascular2

Premarket Submissions#

Submission, Supplement table
SubmissionSupplement
K222358000

Premarket Details#

Submission, Supplement, Device table
SubmissionSupplementDeviceApplicantDecision dateProduct code
K222358000Indigo Aspiration System - Lightning FlashPenumbra, Inc.2022-12-20QEW

Identifiers And Packaging#

Identifier, Type, Agency table
IdentifierTypeAgencyPackage quantityStatus
00815948024830PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815948024830008159480248308159480248300815948024830

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
191077671
Device count
1
Kit
true
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
00815948025134BenchmarkBMK6F95M-A2023-01-05
00815948025141BenchmarkBMK6F105-A2023-01-05
00815948025158BenchmarkBMK6F105M-A2023-01-05
00815948025165BenchmarkBMK6F115-A2023-01-05
00815948025172BenchmarkBMK6F115M-A2023-01-05
00815948025189BenchmarkBMK6F95BER120-A2023-01-05
00815948025196BenchmarkBMK6F95SIM120-A2023-01-05
00815948025202BenchmarkBMK6F95MBER120-A2023-01-05
00815948025219BenchmarkBMK6F95MSIM120-A2023-01-05
00815948025226BenchmarkBMK6F105BER130-A2023-01-05
00815948025233BenchmarkBMK6F105SIM130-A2023-01-05
00815948025240BenchmarkBMK6F105MBER130-A2023-01-05
00815948025257BenchmarkBMK6F105MSIM130-A2023-01-05
00815948022553Indigo SystemLITNG12HTORQ100-A2020-07-15
00815948022560Indigo SystemLITNG12XTORQ100-A2020-07-15
00815948022577Indigo SystemLITNG12HTORQ115-A2020-07-15
00815948022591Indigo SystemLITNG12XTORQ115-A2020-07-15
00815948022904Indigo SystemLITNG12HTORQ1002020-07-15
00815948022911Indigo SystemLITNG12XTORQ1002020-07-15
00815948022928Indigo SystemLITNG12HTORQ1152020-07-15

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850083646028enVast 6.0 x 35 mm - Flow Restoration, 2 Drop Zones - 200 cm wireVesalioQEW2026-03-20
00850083646042enVast 4.5 x 37 mm - Flow Restoration, 2 Drop Zones - 200 cm wireVesalioQEW2026-03-20
00850083646059enVast 4.5 x 46 mm - Flow Restoration, 3 Drop Zones - 200 cm wireVesalioQEW2026-03-20
00850083646066enVast 4.0 x 30 mm - Flow Restoration, 2 Drop Zones - 200 cm wireVesalioQEW2026-03-20
00850044140015Helo Thrombectomy SystemEndovascular Engineering, Inc.QEW2026-03-13
00810169722213Indigo SystemPENUMBRA, INC.QEW2026-03-10
00810169722220Indigo SystemPENUMBRA, INC.QEW2026-03-10
00810169722237Indigo SystemPENUMBRA, INC.QEW2026-03-10
00810169722244Indigo SystemPENUMBRA, INC.QEW2026-03-10
00860008103819Recana Debulking CatheterIntervene, Inc.QEW2026-03-02
00860008103826Recana Collection Basket, 18mmIntervene, Inc.QEW2026-03-02
00860008103833Recana Collection Basket, 30mmIntervene, Inc.QEW2026-03-02
00860008103840Recana Introducer Sheath, 13Fr x 30cmIntervene, Inc.QEW2026-03-02
00860008103857Recana Introducer Sheath, 13Fr x 90cmIntervene, Inc.QEW2026-03-02
00860008103864Recana Introducer Sheath, 16Fr x 30cmIntervene, Inc.QEW2026-03-02
00860008103871Recana Introducer Sheath, 16Fr x 90cmIntervene, Inc.QEW2026-03-02
M917RVHD0RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.QEW2026-02-06
M917RVHD1RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.QEW2026-02-06
M917VRG7513B30RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.QEW2026-02-06
00810123710249Artix AXInari Medical, Inc.QEW2026-01-06
00810123710256Artix AXInari Medical, Inc.QEW2026-01-06
00810169722480Indigo System Lightning Bolt 16PENUMBRA, INC.QEW2025-11-24
00810169722497Indigo System Lightning Bolt 16PENUMBRA, INC.QEW2025-11-24
00810169722503Indigo System Lightning Bolt 16PENUMBRA, INC.QEW2025-11-24
00810169722510Indigo System Lightning Bolt 16PENUMBRA, INC.QEW2025-11-24
00810169722527Indigo System Lightning FlashPENUMBRA, INC.QEW2025-11-24
00810169722534Indigo System Lightning FlashPENUMBRA, INC.QEW2025-11-24
00810169722541Indigo System Lightning FlashPENUMBRA, INC.QEW2025-11-24
00810169722558Indigo System Lightning FlashPENUMBRA, INC.QEW2025-11-24
00763000849801Liberant™MEDTRONIC, INC.QEW2025-11-16