REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER


Device Classification Name

catheter, recording, electrode, reprocessed

510(k) Number K112292
Device Name REPROCESSED 2515 NAV VARIABLE ELECTROPHYSIOLOGY CATHETER
Applicant
STRYKER SUSTAINABILITY SOLUTIONS
1810 w. drake dr.
tempe, 
AZ 
85283

Applicant Contact ramona kulik
Correspondent
STRYKER SUSTAINABILITY SOLUTIONS
1810 w. drake dr.
tempe, 
AZ 
85283

Correspodent Contact ramona kulik
Regulation Number 870.1220
Classification Product Code
NLH  
Date Received 08/10/2011
Decision Date 10/21/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Cardiovascular

510k Review Panel

Cardiovascular

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No