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 K911089
Device Name STEALTH CATHETER SYSTEM
Applicant
TARGET THERAPEUTICS
130 RIO ROBLES
P.O. BOX 610458
SAN JOSE,  CA  95134
Applicant Contact CHARLES T MARONEY
Correspondent
TARGET THERAPEUTICS
130 RIO ROBLES
P.O. BOX 610458
SAN JOSE,  CA  95134
Correspondent Contact CHARLES T MARONEY
Regulation Number870.1250
Classification Product Code
LIT  
Date Received03/05/1991
Decision Date 05/29/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-