MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7


Device Classification Name

introducer, catheter

510(k) Number K080500
Device Name MODIFICATION TO: ACUMEN SINGLE-LUMEN DELIVERY SHEATH, MODELS BLS-10, BLS-9, BLS-7
Applicant
ACUMEN MEDICAL, INC.
275 santa ana court
sunnyvale, 
CA 
94085

Applicant Contact kevin macdonald
Correspondent
ACUMEN MEDICAL, INC.
275 santa ana court
sunnyvale, 
CA 
94085

Correspodent Contact kevin macdonald
Regulation Number 870.1340
Classification Product Code
DYB  
Date Received 02/25/2008
Decision Date 03/13/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No