Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Peripheral Mechanical Thrombectomy With Aspiration
510(k) Number K242319
Device Name Indigo® Aspiration System – Aspiration Catheter 6X
Applicant
Penumbra, Inc.
One Penumbra Place
Alameda,  CA  94502
Applicant Contact Samyukta Rangachari
Correspondent
Penumbra, Inc.
One Penumbra Place
Alameda,  CA  94502
Correspondent Contact Samyukta Rangachari
Regulation Number870.5150
Classification Product Code
QEW  
Date Received08/05/2024
Decision Date 09/03/2024
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-