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, Percutaneous
510(k) Number K093977
Device Name ALLIGATOR-HD RETRIEVAL DEVICE (ARD-HD), MODEL FA-88840-XX
Applicant
CHESTNUT MEDICAL TECHNOLOGIES, INC.
173 JEFFERSON DRIVE
MENLO PARK,  CA  94025 -1114
Applicant Contact DANIEL CHER
Correspondent
CHESTNUT MEDICAL TECHNOLOGIES, INC.
173 JEFFERSON DRIVE
MENLO PARK,  CA  94025 -1114
Correspondent Contact DANIEL CHER
Regulation Number870.1250
Classification Product Code
DQY  
Date Received12/24/2009
Decision Date 04/22/2010
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
-
-