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, nephrostomy
510(k) Number K201165
Device Name In-Ka Percutaneous Balloon Dilatation Catheters, Amplatz Sheath
Applicant
Coloplast Corp
1601 West River Road North
Minneapolis,  MN  55411
Applicant Contact Cori Ragan
Correspondent
Coloplast Corp
1601 West River Road North
Minneapolis,  MN  55411
Correspondent Contact Sihem Darraji
Classification Product Code
LJE  
Date Received05/01/2020
Decision Date 12/17/2020
Decision Substantially Equivalent - Kit (SESK)
510k Review Panel Gastroenterology/Urology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-