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 K083855
Device Name MODIFIED ACUMEN LEAD DELIVERY SHEATH WITH STYLET, MODEL: SPIRIT-10.5-59
Applicant
Acumen Medical, Inc.
275 Santa Ana Court
Sunnyvale,  CA  94085
Applicant Contact KEVIN MACDONALD
Correspondent
Acumen Medical, Inc.
275 Santa Ana Court
Sunnyvale,  CA  94085
Correspondent Contact KEVIN MACDONALD
Regulation Number870.1340
Classification Product Code
DYB  
Date Received12/24/2008
Decision Date 02/17/2009
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
-
-