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, Angioplasty, Peripheral, Transluminal
510(k) Number K171251
Device Name 014 Hydrophilic Coated PTA Balloon Dilatation Catheter
Applicant
Creagh Medical
Ida Business Park
Ballinasloe,  IE H53 K8P4
Applicant Contact Shane Costello
Correspondent
Surmodics
9924 W. 74th St.
Eden Prairie,  MN  55344
Correspondent Contact Shawn Fuller
Regulation Number870.1250
Classification Product Code
LIT  
Date Received04/28/2017
Decision Date 09/08/2017
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
-
-