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, Therapeutic, Long-Term Greater Than 30 Days
510(k) Number K961336
Device Name MEDTRONIC VASCULAR CATHETER, MULTI LUMEN MODELS 84640, 84652
Applicant
Medtronic PS Medical
125 Cremona Dr.
Goleta,  CA  93117
Applicant Contact TOM HOLDYCH
Correspondent
Medtronic PS Medical
125 Cremona Dr.
Goleta,  CA  93117
Correspondent Contact TOM HOLDYCH
Regulation Number880.5970
Classification Product Code
LJS  
Date Received04/08/1996
Decision Date 07/18/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-