PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS


Device Classification Name

catheter, continuous flush

510(k) Number K021591
Device Name PROWLER SELECT (10, 14, AND PLUS) INFUSION CATHETERS WITH AND WITHOUT PRE-SHAPED TIPS
Original Applicant
CORDIS NEUROVASCULAR, INC.
14000 n.w. 57th ct.
miami lakes, 
FL 
33014

Original Contact maritza celaya
Regulation Number 870.1210
Classification Product Code
KRA  
Date Received 05/15/2002
Decision Date 05/22/2002
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