Indigo Aspiration System

GUDID 00814548019703

IS ENGINE Canister Assembly

PENUMBRA, INC.

Surgical irrigation/aspiration system
Primary Device ID00814548019703
NIH Device Record Keya7b5c151-4b0d-4916-b76c-8b8c2d109845
Commercial Distribution StatusIn Commercial Distribution
Brand NameIndigo Aspiration System
Version Model NumberIAPS3-A
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 Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptionfalse
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS100814548019703 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

DXECatheter, Embolectomy

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2018-11-08
Device Publish Date2018-10-08

Devices Manufactured by PENUMBRA, INC.

00810169721896 - Swift Coil System2025-05-22 Swift Complex CL, 1mm x 2cm
00810169721902 - Swift Coil System2025-05-22 Swift Complex CL, 1mm x 3cm
00810169721919 - Swift Coil System2025-05-22 Swift Complex CL, 1mm x 5cm
00810169721926 - Swift Coil System2025-05-22 Swift Complex CL, 2mm x 2cm
00810169721933 - Swift Coil System2025-05-22 Swift Complex CL, 2mm x 4cm
00810169721940 - Swift Coil System2025-05-22 Swift Complex CL, 2mm x 10cm
00810169721957 - Swift Coil System2025-05-22 Swift Complex CL, 3mm x 6cm
00810169721964 - Swift Coil System2025-05-22 Swift Complex CL, 3mm x 10cm

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