Biotronik, GmbH & Co. - FDA 510(k) Cleared Devices

Cleared Apr 06, 2000

PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051

K000763 · DTB

Cardiovascular · 28d

Cleared Sep 22, 1993

BIOSCOPE

K923406 · DPS

Cardiovascular · 439d

Cleared Aug 19, 1993

PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER

K923026 · DXY

Cardiovascular · 422d

Cleared Mar 18, 1993

HPM 40 HEART PACEMAKER MONITOR

K922742 · KRE

Cardiovascular · 283d

Cleared Feb 26, 1992

PIKOS 01 & PIKOS E 01

K914109 · DXY

Cardiovascular · 166d

Cleared Aug 28, 1991

PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIP

K910609 · DTB

Cardiovascular · 197d

Cleared Aug 09, 1991

LEAD TERMINAL PIN CAPS, VARIOUS MODELS

K911142 · DTD

Cardiovascular · 148d

Cleared Jul 30, 1991

PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIP

K910608 · DTB

Cardiovascular · 168d

Cleared May 07, 1991

TRIOS 02

K905087 · DXY

Cardiovascular · 175d

Cleared Oct 16, 1990

LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 45-UP

K903927 · DTB

Cardiovascular · 57d

Cleared Oct 16, 1990

LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP

K903928 · DTB

Cardiovascular · 57d

Cleared Oct 16, 1990

LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 60-UP

K903929 · DTB

Cardiovascular · 57d

Cleared Sep 14, 1990

NEOS (TM) 02 B PULSE GENERATOR

K903081 · DXY

Cardiovascular · 64d

Cleared Aug 23, 1990

A1-A,A1-B,A1-ABP,A1-MBP,A1-Z,A6-A,A6-B,PEH PACE.

K902889 · DTD

Cardiovascular · 52d

Cleared Aug 08, 1990

BIOTRONIK'S PS-ENDOCARDIAL LEADS

K896824 · DTB

Cardiovascular · 247d

Cleared May 22, 1990

DNP 60-B UNIPOLAR ENDOCARDIAL LEAD

K901709 · DTB

Cardiovascular · 39d

Cleared May 09, 1990

PK-55 ANDOVER MEDICAL PART #5455 LABEL CHANGE

K901332 · DTC

Cardiovascular · 48d

Cleared Oct 17, 1989

LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD

K894494 · DXY

Cardiovascular · 90d