CONSTELLATION CATHETERS, MODEL 8031M


Device Classification Name

catheter,intracardiac mapping,high-density array

510(k) Number K021232
Device Name CONSTELLATION CATHETERS, MODEL 8031M
Original Applicant
BOSTON SCIENTIFIC CORP.
2710 orchard pkwy.
san jose, 
CA 
95134

Original Contact christina l rowe
Regulation Number 870.1220
Classification Product Code
MTD  
Date Received 04/18/2002
Decision Date 05/16/2002
Decision

se – with limitations

(SESU)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls