ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE


Device Classification Name

wire, guide, catheter

510(k) Number K992169
Device Name ACS HI-TORQUE CROSS-IT 400XT GUIDE WIRE
Applicant
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
3200 lakeside dr.
santa clara, 
CA 
95052 -8167

Applicant Contact margaret anderson
Correspondent
ADVANCED CARDIOVASCULAR SYSTEMS, INC.
3200 lakeside dr.
santa clara, 
CA 
95052 -8167

Correspodent Contact margaret anderson
Regulation Number 870.1330
Classification Product Code
DQX  
Date Received 06/28/1999
Decision Date 10/28/1999
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No