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, Percutaneous
510(k) Number K083596
Device Name REEKROSS FAMILY OR OTW PTA CATHETERS
Applicant
ClearStream Technologies , Ltd.
Moyne Upper
Enniscorthy
Wexford,  IE
Applicant Contact FIONA N MHULLAIN
Correspondent
Dekra Certification B.V
Utrechtseweg 310
Arnhem,  NL NL-6812 AR
Correspondent Contact J SCHAKENRAAD
Regulation Number870.1250
Classification Product Code
DQY  
Date Received12/05/2008
Decision Date 03/02/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-