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FDA 510(k) Application Details - K003454
Device Classification Name
Pacemaker Lead Adaptor
More FDA Info for this Device
510(K) Number
K003454
Device Name
Pacemaker Lead Adaptor
Applicant
BIOTRONIK, INC.
6024 JEAN ROAD
LAKE OSWEGO, OR 97035 US
Other 510(k) Applications for this Company
Contact
JON BURMBAUGH
Other 510(k) Applications for this Contact
Regulation Number
870.3620
More FDA Info for this Regulation Number
Classification Product Code
DTD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/07/2000
Decision Date
01/18/2001
Decision
ST - Substantially Equivalent - Subject to Tracking Reg.
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Type
Special
Reviewed By Third Party
N
Expedited Review
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