Indigo System Lightning Flash LITNGFHT80H1

GUDID 00810169722558

Indigo System Lightning Flash Aspiration Tubing, Aspiration Catheter 16 80cm HTORQ Tip, Select+ 100cm H1 Tip

PENUMBRA, INC.

Thrombectomy suction catheter
Primary Device ID00810169722558
NIH Device Record Key1dd68536-ef5a-413f-9d79-121eb080baf4
Commercial Distribution StatusIn Commercial Distribution
Brand NameIndigo System Lightning Flash
Version Model NumberLITNGFHT80H1-F
Catalog NumberLITNGFHT80H1
Company DUNS191077671
Company NamePENUMBRA, INC.
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kittrue
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latextrue
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone1-888-272-4606
Emailinfo@penumbrainc.com
Phone1-888-272-4606
Emailinfo@penumbrainc.com
Phone1-888-272-4606
Emailinfo@penumbrainc.com
Phone1-888-272-4606
Emailinfo@penumbrainc.com
Phone1-888-272-4606
Emailinfo@penumbrainc.com
Phone1-888-272-4606
Emailinfo@penumbrainc.com
Phone1-888-272-4606
Emailinfo@penumbrainc.com
Phone1-888-272-4606
Emailinfo@penumbrainc.com
Phone1-888-272-4606
Emailinfo@penumbrainc.com
Phone1-888-272-4606
Emailinfo@penumbrainc.com
Phone1-888-272-4606
Emailinfo@penumbrainc.com

Device Identifiers

Device Issuing AgencyDevice ID
GS100810169722558 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QEWPeripheral Mechanical Thrombectomy With Aspiration

Sterilization

Steralize Prior To Usefalse
Device Is Steriletrue

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2025-12-02
Device Publish Date2025-11-24

On-Brand Devices [Indigo System Lightning Flash]

00810169722558Indigo System Lightning Flash Aspiration Tubing, Aspiration Catheter 16 80cm HTORQ Tip, Select+
00810169722541Indigo System Lightning Flash Aspiration Tubing, Aspiration Catheter 16 100cm XTORQ Tip, Select+
00810169722534Indigo System Lightning Flash Aspiration Tubing, Aspiration Catheter 16 100cm HTORQ Tip, Select+
00810169722527Indigo System Lightning Flash Aspiration Tubing, Aspiration Catheter 16 115cm HTORQ Tip, Select+

© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.