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, Embolectomy
510(k) Number K992933
Device Name LEMAITRE IRRIGATION CATHETER
Applicant
Vascutech, Inc.
164 Middlesex Turnpike
Burlington,  MA  01803
Applicant Contact TRENT G KAMKE
Correspondent
Vascutech, Inc.
164 Middlesex Turnpike
Burlington,  MA  01803
Correspondent Contact TRENT G KAMKE
Regulation Number870.5150
Classification Product Code
DXE  
Date Received08/31/1999
Decision Date 03/08/2000
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
-
-