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 K123358
Device Name PACIFIC PLUS
Applicant
MEDTRONIC VASCULAR
3576 Unocal Place
Santa Rosa,  CA  95403
Applicant Contact DIANA JOHNSON
Correspondent
MEDTRONIC VASCULAR
3576 Unocal Place
Santa Rosa,  CA  95403
Correspondent Contact DIANA JOHNSON
Regulation Number870.1250
Classification Product Code
LIT  
Subsequent Product Code
DQY  
Date Received10/31/2012
Decision Date 01/29/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-