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 K210083
Device Name Indigo System Aspiration Catheter 7, Indigo Aspiration System Separator 7, Lightning 7
Applicant
Penumbra, Inc.
One Penumbra Pl.
Alameda,  CA  94502
Applicant Contact Teri Nguyen
Correspondent
Penumbra, Inc.
One Penumbra Pl.
Alameda,  CA  94502
Correspondent Contact Teri Nguyen
Regulation Number870.5150
Classification Product Code
QEW  
Date Received01/12/2021
Decision Date 02/09/2021
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
-
-