BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER


Device Classification Name

catheter, percutaneous

510(k) Number K111963
Device Name BRIDGEPOINT MEDICAL MANTARAY(TM) CATHETER
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 870.1250
Classification Product Code
DQY  
Date Received 07/11/2011
Decision Date 08/10/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No