• 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 | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC | Inspections
 


New Search Back To Search Results
Device Classification Name catheter, hemodialysis, implanted
510(k) Number K121848
Device Name SPLIT CATH III 24CM SPLIT CATH III 24CM SPLIT CATH III 32CM CATH III 36CM SPLIT CATH III 40CM AND 55CM
Original Applicant
MEDICAL COMPONENTS INC
1499 delp drive
harleysville,  PA  19438
Original Contact jean callow
Regulation Number876.5540
Classification Product Code
MSD  
Date Received06/25/2012
Decision Date 09/21/2012
Decision substantially equivalent - kit (SESK)
Regulation Medical Specialty Gastroenterology/Urology
510k Review Panel Gastroenterology/Urology
statement statement
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-