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 Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
510(k) Number K020233
Device Name CHASE CARDIOVASCULAR PATCH KIT
Applicant
Chase Medical, Inc.
1710 Firman Dr.
Suite 100
Richardson,  TX  75081
Applicant Contact DAVE HERNON
Correspondent
Chase Medical, Inc.
1710 Firman Dr.
Suite 100
Richardson,  TX  75081
Correspondent Contact DAVE HERNON
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received01/23/2002
Decision Date 03/14/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-