QUICKCAT EXTRACTION CATHETER, MODEL 60090-01


Device Classification Name

catheter, embolectomy

510(k) Number K073519
Device Name QUICKCAT EXTRACTION CATHETER, MODEL 60090-01
Applicant
KENSEY NASH CORP.
735 pennsylvania drive
exton, 
PA 
19341

Applicant Contact cindy varughese
Correspondent
KENSEY NASH CORP.
735 pennsylvania drive
exton, 
PA 
19341

Correspodent Contact cindy varughese
Regulation Number 870.5150
Classification Product Code
DXE  
Date Received 12/14/2007
Decision Date 03/28/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls