LUMA-CATH STEERABLE EP CATHETERS


Device Classification Name

catheter, electrode recording, or probe, electrode recording

510(k) Number K991878
Device Name LUMA-CATH STEERABLE EP CATHETERS
Applicant
IRVINE BIOMEDICAL, INC.
2146-a michelson dr.
irvine, 
CA 
92612

Applicant Contact roger tu
Correspondent
IRVINE BIOMEDICAL, INC.
2146-a michelson dr.
irvine, 
CA 
92612

Correspodent Contact roger tu
Regulation Number 870.1220
Classification Product Code
DRF  
Date Received 06/02/1999
Decision Date 12/10/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized