FDA.report

Indigo System

Primary DI
00815948029453
Brand
Indigo System
Company
PENUMBRA, INC.
Model
LITNGFHT115BER-C
Device description
CAT16 HTORQ 115cm, Select 135cm BER Tip, Lightning Flash Tubing
Published
2024-03-21
Public version status
New
Distribution status
In Commercial Distribution
MRI safety
Labeling does not contain MRI Safety Information
Rx
true
OTC
false
Sterile
true
Single use
true

Related Records

Product Codes

CodeName
QEWPeripheral Mechanical Thrombectomy With Aspiration

Product Code Classifications

CodeDeviceSpecialtyClass
QEWPeripheral Mechanical Thrombectomy With AspirationCardiovascular2

Premarket Submissions

SubmissionSupplement
K240030000

Premarket Details

SubmissionSupplementDeviceApplicantDecision dateProduct code
K240030000Indigo® Aspiration System - Lightning® FlashPenumbra, Inc.2024-02-02QEW

Identifiers And Packaging

IdentifierTypeAgencyPackage quantityStatus
00815948029453PrimaryGS10

GMDN Terms

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.

Sterilization Methods

Method

Regulatory Flags

DUNS number
191077671
Device count
1
DM exempt
false
Premarket exempt
false
HCT/P
false
Kit
true
Combination product
false
Lot or batch
true
Serial number
false
Manufacturing date on label
false
Expiration date on label
true
Donation ID number
false
Contains natural rubber latex
false
No natural rubber latex
true
Sterilization required before use
false

Other Devices From This Company

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00810169722237Indigo SystemLITNGFHT100H1-ELITNGFHT100H12026-03-10
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00810169722039swiftMATCH Coil, Extra Soft400SWXSFT101-A400SWXSFT1012026-01-26
00810169722046swiftMATCH Coil, Extra Soft400SWXSFT102-A400SWXSFT1022026-01-26
00810169722053swiftMATCH Coil, Extra Soft400SWXSFT103-A400SWXSFT1032026-01-26
00810169722060swiftMATCH Coil, Extra Soft400SWXSFT105-A400SWXSFT1052026-01-26
00810169722077swiftMATCH Coil, Extra Soft400SWXSFT202-A400SWXSFT2022026-01-26
00810169722084swiftMATCH Coil, Extra Soft400SWXSFT204-A400SWXSFT2042026-01-26
00810169722091swiftMATCH Coil, Extra Soft400SWXSFT206-A400SWXSFT2062026-01-26
00810169722107swiftMATCH Coil, Extra Soft400SWXSFT304-A400SWXSFT3042026-01-26
00810169722114swiftMATCH Coil, Extra Soft400SWXSFT306-A400SWXSFT3062026-01-26
00810169722121swiftMATCH Coil, Extra Soft400SWXSFT308-A400SWXSFT3082026-01-26
00810169722138swiftMATCH Coil, Extra Soft400SWXSFT406-A400SWXSFT4062026-01-26
00810169722145swiftMATCH Coil, Extra Soft400SWXSFT408-A400SWXSFT4082026-01-26
00810169722152swiftMATCH Coil, Extra Soft400SWXSFT410-A400SWXSFT4102026-01-26
00810169722169swiftMATCH Coil, Soft400SWSFT306-A400SWSFT3062026-01-26
00810169722176swiftMATCH Coil, Soft400SWSFT406-A400SWSFT4062026-01-26
00810169722183swiftMATCH Coil, Soft400SWSFT410-A400SWSFT4102026-01-26

Other Devices Sharing Product Codes

Primary DIBrandCompanyProduct codePublished
00810169722213Indigo SystemPENUMBRA, INC.QEW2026-03-10
00810169722220Indigo SystemPENUMBRA, INC.QEW2026-03-10
00810169722237Indigo SystemPENUMBRA, INC.QEW2026-03-10
00810169722244Indigo SystemPENUMBRA, INC.QEW2026-03-10
M917RVHD1RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.QEW2026-02-06
M917VRG7513B30RoVo Mechanical Thrombectomy SystemVerge Medical, Inc.QEW2026-02-06
00810123710249Artix AXINARI MEDICAL INCQEW2026-01-06
00810123710256Artix AXINARI MEDICAL INCQEW2026-01-06
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
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00763000998646Liberant™MEDTRONIC, INC.QEW2025-11-16
00860009303447Aventus Thrombectomy SystemInquis Medical, Inc.QEW2025-08-20
00810169722466Indigo SystemPENUMBRA, INC.QEW2025-08-19
00810169722473Indigo SystemPENUMBRA, INC.QEW2025-08-19
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00810123710126InThrill Thrombectomy CatheterINARI MEDICAL INCQEW2025-05-30
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00850291007352InThrill Thrombectomy CatheterINARI MEDICAL INCQEW2024-12-20
00812339030807Pounce ™ XL ThrombectomySurmodics, Inc.QEW2024-11-13