MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003


Device Classification Name

wire, guide, catheter

510(k) Number K111488
Device Name MANTARAY GUIDEWIRE MODEL M-6000, M-6001, M-6002, M-6003
Applicant
BRIDGEPOINT MEDICAL
2800 campus dr ste 50
plymouth, 
MN 
55441

Applicant Contact jill munsinger
Correspondent
BRIDGEPOINT MEDICAL
2800 campus dr ste 50
plymouth, 
MN 
55441

Correspodent Contact jill munsinger
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 05/31/2011
Decision Date 06/30/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

Type Special
Reviewed by Third Party No

Combination Product

No