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 temporary carotid catheter for embolic capture
510(k) Number K210282
Device Name WIRION Embolic Protection System
Applicant
Cardiovascular Systems Inc.
1225 Old Hwy 8 NW
St. Paul,  MN  55112
Applicant Contact Erika Huffman
Correspondent
Cardiovascular Systems Inc.
1225 Old Hwy 8 NW
St. Paul,  MN  55112
Correspondent Contact Erika Huffman
Regulation Number870.1250
Classification Product Code
NTE  
Date Received02/01/2021
Decision Date 03/03/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-