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 K972684
Device Name INNERDYNE RADIALLY EXPANDING VASCULAR ACCESS SYSTEM
Applicant
Innerdyne, Inc.
5060 W. Amelia Earhart Dr.
Salt Lake City,  UT  84116
Applicant Contact RICK GAYKOWSKI
Correspondent
Innerdyne, Inc.
5060 W. Amelia Earhart Dr.
Salt Lake City,  UT  84116
Correspondent Contact RICK GAYKOWSKI
Regulation Number870.1340
Classification Product Code
DYB  
Date Received07/17/1997
Decision Date 10/10/1997
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
-
-