CONSTELLATION CATHETERS


definition

Device Classification Name

catheter,intracardiac mapping,high-density array

510(k) Number K000277
Device Name CONSTELLATION CATHETERS
Original Applicant
BOSTON SCIENTIFIC CORP.
2710 orchard pkwy.
san jose, 
CA 
95134

Original Contact andrea boumis
Regulation Number 870.1220
Classification Product Code
MTD  
Date Received 01/31/2000
Decision Date 09/26/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls