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, percutaneous
510(k) Number K913517
Device Name ISOLATE INFUSION CATHETR SYSTEM
Applicant
LAKE REGION MFG., INC.
340 LAKE HAZELTINE DR.
CHASKA,  MN  55318
Applicant Contact PAUL KOHL
Correspondent
LAKE REGION MFG., INC.
340 LAKE HAZELTINE DR.
CHASKA,  MN  55318
Correspondent Contact PAUL KOHL
Regulation Number870.1250
Classification Product Code
DQY  
Date Received08/07/1991
Decision Date 11/05/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-