SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028


Device Classification Name

catheter, percutaneous

510(k) Number K022138
Device Name SPECTRANETICS 0.035 SUPPORT CATHETER, MODEL 518-028
Original Applicant
SPECTRANETICS CORP.
96 talamine ct.
colorado springs, 
CO 
80907 -5159

Original Contact michael j ryan
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 07/02/2002
Decision Date 09/23/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No