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 K233503
Device Name 14F iSLEEVE Introducer Set
Applicant
Boston Scientific Corporation
Two Scimed Place
Maple Grove,  MN  55311
Applicant Contact Alyssa Manno
Correspondent
Boston Scientific Corporation
Two Scimed Place
Maple Grove,  MN  55311
Correspondent Contact Alyssa Manno
Regulation Number870.1340
Classification Product Code
DYB  
Date Received10/31/2023
Decision Date 11/30/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
-
-