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 Wire, Guide, Catheter
510(k) Number K934602
Device Name ACS.018 HI-TORQUE FLOPPY GUIDE WIRE - ACS HI-TORQUE FLOPPY EXTRA SUPPORT GUIDE WIRE
Applicant
Advanced Cardiovascular Systems, Inc.
3200 Lakeside Dr.
P.O. Box 58167
Santa Clara,  CA  95052 -8167
Applicant Contact MICHAEL KOLBER
Correspondent
Advanced Cardiovascular Systems, Inc.
3200 Lakeside Dr.
P.O. Box 58167
Santa Clara,  CA  95052 -8167
Correspondent Contact MICHAEL KOLBER
Regulation Number870.1330
Classification Product Code
DQX  
Date Received09/24/1993
Decision Date 12/16/1993
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
-
-