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 K252057
Device Name Symphony™ Thrombectomy System and Symphony™ 16F 82cm Thrombectomy System
Applicant
Imperative Care, Inc.
1359 Dell Ave.
Campbell,  CA  95008
Applicant Contact Shivani Patel
Correspondent
Imperative Care, Inc.
1359 Dell Ave.
Campbell,  CA  95008
Correspondent Contact Shivani Patel
Regulation Number870.5150
Classification Product Code
QEW  
Subsequent Product Code
KRA  
Date Received07/01/2025
Decision Date 08/28/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Clinical Trials NCT06062329
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-