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, Angioplasty, Peripheral, Transluminal
510(k) Number K221832
Device Name SABER .014 PTA Dilatation Catheter; SABERX .014 PTA Dilatation Catheter
Applicant
Cordis US Corp
14201 NW 60th Ave.
Miami Lakes,  FL  33014
Applicant Contact Luis Davila
Correspondent
Cordis US Corp
5452 Betsy Ross Dr.
Santa Clara,  CA  95054
Correspondent Contact Gina Flores
Regulation Number870.1250
Classification Product Code
LIT  
Date Received06/23/2022
Decision Date 08/22/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-