MICROSHEATH XL CATHETERS


Device Classification Name

catheter, percutaneous

510(k) Number K073289
Device Name MICROSHEATH XL CATHETERS
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 11/21/2007
Decision Date 01/11/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No