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FDA 510(k) Application Details - K010281
Device Classification Name
Permanent Pacemaker Electrode
More FDA Info for this Device
510(K) Number
K010281
Device Name
Permanent Pacemaker Electrode
Applicant
BIOTRONIK, INC.
6024 JEAN ROAD
LAKE OSWEGO, OR 97035 US
Other 510(k) Applications for this Company
Contact
Jon Brumbaugh
Other 510(k) Applications for this Contact
Regulation Number
870.3680
More FDA Info for this Regulation Number
Classification Product Code
DTB
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
01/30/2001
Decision Date
04/09/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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