BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL GUIDEWIRE, MODEL M-3001


Device Classification Name

wire, guide, catheter

510(k) Number K081187
Device Name BRIDGEPOINT MEDICAL ENTERA PERCUTANEOUS CORONARY AND PERIPHERAL GUIDEWIRE, MODEL M-3001
Applicant
BRIDGEPOINT MEDICAL
8 snowberry court
orinda, 
CA 
94563

Applicant Contact michael a daniel
Correspondent
BRIDGEPOINT MEDICAL
8 snowberry court
orinda, 
CA 
94563

Correspodent Contact michael a daniel
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 04/28/2008
Decision Date 10/08/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No