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 Aspiration Thrombectomy Catheter
510(k) Number K110315
Device Name NEXGEN PERIPHERAL MECHANICAL RETRIEVAL DEVICE
Applicant
Nexgen Medical Systems, Inc.
1050 W. Nasa Blvd.
Suite 136
Melbourne,  FL  32901
Applicant Contact CRAIG PAGAN
Correspondent
Nexgen Medical Systems, Inc.
1050 W. Nasa Blvd.
Suite 136
Melbourne,  FL  32901
Correspondent Contact CRAIG PAGAN
Regulation Number870.5150
Classification Product Code
QEZ  
Date Received02/02/2011
Decision Date 10/20/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-