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 Introducer, Catheter
510(k) Number K900658
Device Name INTRODUCER, PERCUTANEOUS
Applicant
Novoste Puerto Rico, Inc.
P.O. Box 5149
Aguadilla, Puerto Rico, 
Applicant Contact CHARLES LARSEN
Correspondent
Novoste Puerto Rico, Inc.
P.O. Box 5149
Aguadilla, Puerto Rico, 
Correspondent Contact CHARLES LARSEN
Regulation Number870.1340
Classification Product Code
DYB  
Date Received02/09/1990
Decision Date 08/23/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-