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 K921659
Device Name ULTRA LOW POROSITY DACRON WOVEN PATCH
Applicant
Intervascular, Inc.
16331 Bay Vista Dr.
Clearwater,  FL  33760
Applicant Contact DENISE ENG
Correspondent
Intervascular, Inc.
16331 Bay Vista Dr.
Clearwater,  FL  33760
Correspondent Contact DENISE ENG
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received04/07/1992
Decision Date 11/25/1992
Decision SE - Postmarket Surveillance Required (SESP)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-