CARDIA-CATH


Device Classification Name

transducer, pressure, catheter tip

510(k) Number K112323
Device Name CARDIA-CATH
Applicant
MILLAR INSTRUMENTS, INC.
6001-a gulf freeway
houston, 
TX 
77023 -5417

Applicant Contact fatma m ali
Correspondent
MILLAR INSTRUMENTS, INC.
6001-a gulf freeway
houston, 
TX 
77023 -5417

Correspodent Contact fatma m ali
Regulation Number 870.2870
Classification Product Code
DXO  
Date Received 08/12/2011
Decision Date 10/18/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No