SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066


Device Classification Name

catheter, percutaneous

510(k) Number K072750
Device Name SPECTRANETICS QUICK-CROSS SUPPORT2 CATHETERS, MODELS 518-065 AND 518-066
Applicant
SPECTRANETICS CORP.
96 talamine ct.
colorado springs, 
CO 
80907 -5159

Applicant Contact michael k handley
Correspondent
SPECTRANETICS CORP.
96 talamine ct.
colorado springs, 
CO 
80907 -5159

Correspodent Contact michael k handley
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 09/27/2007
Decision Date 12/04/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No