Biotronik, Inc. - FDA 510(k) Cleared Devices

Not Cleared Jan 27, 1998

ELC 35-UP MODEL NUMBER 116015 AND ELC 54-UP MODEL NUMBER 115606

K965106 · DTB

Cardiovascular · 403d

Not Cleared Aug 14, 1997

A1-A,ABP,B,MBP, LEAD CONNECTORS

K970388 · DTD

Cardiovascular · 192d

Not Cleared Aug 14, 1997

BK-N SEALING CAP

K971930 · DTD

Cardiovascular · 79d

Cleared Jul 10, 1997

ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER

K964190 · DTE

Cardiovascular · 262d

Cleared Apr 29, 1997

BK-A

K970204 · DTD

Cardiovascular · 98d

Not Cleared Mar 10, 1997

BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER INSULATION...

K964604 · DTB

Cardiovascular · 112d

Not Cleared Sep 27, 1996

UNIPOLAR & BIOPLAR IMPLANTABLE ENDOCARDIAL PACING LEADS, WITH SILICONE RUBBER...

K953044 · DTB

Cardiovascular · 455d

Cleared Mar 04, 1996

PIKOS LP 01, PIKOS LP E01

K945627 · DXY

Cardiovascular · 474d

Cleared Sep 29, 1995

NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01

K952328 · DXY

Cardiovascular · 134d

Cleared Aug 30, 1994

PIKOS E 01-B

K941937 · DXY

Cardiovascular · 131d