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, intravascular, diagnostic
510(k) Number K000825
Device Name 4F-7F MEDI-DYNE TORQ FLOW XLB ANGIOGRAPHIC CATHETER
Applicant
MEDI-DYNE, INC.
604 QUEENSBURY AVE.
QUEENSBURY,  NY  12804
Applicant Contact NORMAN HALL
Correspondent
MEDI-DYNE, INC.
604 QUEENSBURY AVE.
QUEENSBURY,  NY  12804
Correspondent Contact NORMAN HALL
Regulation Number870.1200
Classification Product Code
DQO  
Date Received03/14/2000
Decision Date 09/21/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-