MICROSHEATH LP AND LP-AT


Device Classification Name

catheter, percutaneous

510(k) Number K080849
Device Name MICROSHEATH LP AND LP-AT
Applicant
FLOWCARDIA, INC.
745 n. pastoria ave.
sunnyvale, 
CA 
94085

Applicant Contact dustin michaels
Correspondent
FLOWCARDIA, INC.
745 n. pastoria ave.
sunnyvale, 
CA 
94085

Correspodent Contact dustin michaels
Regulation Number 870.1250
Classification Product Code
DQY  
Date Received 03/26/2008
Decision Date 07/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No