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 Catheter, Thrombus Retriever
510(k) Number K251828
Device Name CEREGLIDE 71 Catheter System; Cerenovus Aspiration Tubing Set
Applicant
Cerenovus, Inc.
6303 Waterford District Dr., Suites 215 & 315
Miami,  FL  33126
Applicant Contact Cara Feely
Correspondent
Cerenovus, Inc.
6303 Waterford District Dr., Suites 215 & 315
Miami,  FL  33126
Correspondent Contact Cara Feely
Regulation Number870.1250
Classification Product Code
NRY  
Subsequent Product Code
QJP  
Date Received06/13/2025
Decision Date 08/22/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Neurology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-