FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12


Device Classification Name

catheter, steerable

510(k) Number K081049
Device Name FLEXCATH STEERABLE SHEATH & DILATOR, MODELS 3FC10, 3FC12
Applicant
CRYOCATH TECHNOLOGIES, INC.
52 west basin ridge
galisteo, 
NM 
87540

Applicant Contact fred milder
Correspondent
CRYOCATH TECHNOLOGIES, INC.
52 west basin ridge
galisteo, 
NM 
87540

Correspodent Contact fred milder
Regulation Number 870.1280
Classification Product Code
DRA  
Date Received 04/14/2008
Decision Date 06/27/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No