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, Embolectomy
510(k) Number K961992
Device Name NEEDLE'S EYE SNARE
Applicant
Cook Pacemaker Corp.
Route 66 River Rd.
P.O. Box 529
Leechburg,  PA  15656
Applicant Contact NEAL E FEARNOT
Correspondent
Cook Pacemaker Corp.
Route 66 River Rd.
P.O. Box 529
Leechburg,  PA  15656
Correspondent Contact NEAL E FEARNOT
Regulation Number870.5150
Classification Product Code
DXE  
Date Received05/21/1996
Decision Date 12/27/1996
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
-
-