FDA.reportPublic FDA data

Indigo System

Primary DI
00815948024878
Brand
Indigo System
Company
PENUMBRA, INC.
Model
LITNGFXT100BER-A
Device description
CAT16 XTORQ 100cm, Select 135cm BER 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
00815948024878PrimaryGS10

Alternate GTIN / UPC / EAN Codes

Source identifier, GTIN-14 normalized, UPC-A table
Source identifierGTIN-14 normalizedUPC-AEAN-13
00815948024878008159480248788159480248780815948024878

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
00810169723586swiftMATCH Coil, Extra Soft400SWXSFT510-A400SWXSFT5102026-10-01
00810169723593swiftMATCH Coil, Extra Soft400SWXSFT615-A400SWXSFT6152026-10-01
00810169723609swiftMATCH Coil, Soft400SWSFT610-A400SWSFT6102026-10-01
00810169723616swiftMATCH Coil, Soft400SWSFT615-A400SWSFT6152026-10-01
00810169723623swiftMATCH Coil, Soft400SWSFT715-A400SWSFT7152026-10-01
00810169723630swiftMATCH Coil, Soft400SWSFT820-A400SWSFT8202026-10-01
00810169723647swiftMATCH Coil, Standard400SWSTD408-A400SWSTD4082026-10-01
00810169723654swiftMATCH Coil, Standard400SWSTD510-A400SWSTD5102026-10-01
00810169723661swiftMATCH Coil, Standard400SWSTD515-A400SWSTD5152026-10-01
00810169723678swiftMATCH Coil, Standard400SWSTD615-A400SWSTD6152026-10-01
00810169723685swiftMATCH Coil, Standard400SWSTD620-A400SWSTD6202026-10-01
00810169723692swiftMATCH Coil, Standard400SWSTD725-A400SWSTD7252026-10-01
00810169723708swiftMATCH Coil, Standard400SWSTD830-A400SWSTD8302026-10-01
00810169724217Ruby XL Coil SystemRBYPODXL0310-ARBYPODXL03102026-10-01
00810169724224Ruby XL Coil SystemRBYPODXL0320-ARBYPODXL03202026-10-01
00810169724231Ruby XL Coil SystemRBYPODXL0720-ARBYPODXL07202026-10-01
00810169724248Ruby XL Coil SystemRBYPODXL0755-ARBYPODXL07552026-10-01
00810169724255Ruby XL Coil SystemRBYPODXL0830-ARBYPODXL08302026-10-01
00810169724262Ruby XL Coil SystemRBYPODXL0930-ARBYPODXL09302026-10-01
00810169724279Ruby XL Coil SystemRBYPODXL0955-ARBYPODXL0955-A2026-10-01

Other Devices Sharing Product Codes#

Primary DI, Brand, Company table
Primary DIBrandCompanyProduct codePublished
00850044140022Helo Max Thrombectomy SystemEndovascular Engineering, Inc.QEW2026-09-29
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