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 Introducer, Catheter
510(k) Number K203459
FOIA Releasable 510(k) K203459
Device Name SafeCross Transseptal Puncture and Introducer (TSP/I) System
Applicant
East End Medical I, LLC
1157 Sawgrass Corporate Pkwy.
Sunrise,  FL  33323
Applicant Contact Brij Maini
Correspondent
Mandell Horwitz Consultants, LLC
5 Lake Como Ct.
Greenville,  SC  29609
Correspondent Contact Diane Horwitz
Regulation Number870.1340
Classification Product Code
DYB  
Subsequent Product Code
DXF  
Date Received11/24/2020
Decision Date 07/06/2021
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
-
-