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 K920331
Device Name RIGHT ATRIAL CATHETER KITS
Applicant
AKCESS MEDICAL PRODUCTS, INC.
201 NORTH CENTER DR.
NEW BRUNSWICK,  NJ  08902
Applicant Contact BALBIR KAPANY
Correspondent
AKCESS MEDICAL PRODUCTS, INC.
201 NORTH CENTER DR.
NEW BRUNSWICK,  NJ  08902
Correspondent Contact BALBIR KAPANY
Regulation Number870.1250
Classification Product Code
DQY  
Date Received01/23/1992
Decision Date 04/22/1992
Decision Substantially Equivalent - Kit (SESK)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-