Pacesetter Systems - FDA 510(k) Cleared Devices

Cleared Sep 04, 1979

MODELS UL-804 AND BL-801 UNIPOLAR LEADS

K791552 · DTB

Cardiovascular · 21d

Cleared Aug 10, 1979

PULSE GENERATOR, R WAVE DEMAND

K790141 · DXY

Cardiovascular · 203d

Cleared Aug 10, 1979

BIPOLAR LEAD ADAPTOR, MODEL BA-415

K790218 · DTD

Cardiovascular · 192d

Cleared Aug 10, 1979

MDL-201A & T DL-201A PULSE GENERATOR

K790428 · DXY

Cardiovascular · 162d

Cleared Oct 27, 1978

PACING LEADS MODEL UL-811 AND UL-813

K781776 · DTB

Cardiovascular · 14d

Cleared Sep 27, 1978

GENERATORS: UDL-201B, BDL-201B, MDL-201B

K781424 · DXY

Cardiovascular · 41d

Cleared Jan 30, 1978

TDL-100 B

K772050 · DXY

Cardiovascular · 91d

Cleared Jan 30, 1978

MDL-201

K772051 · DXY

Cardiovascular · 91d

Cleared Sep 14, 1977

UNIVERSAL LEAD ADAPTER, UA-414

K771641 · DTD

Cardiovascular · 16d

Cleared Sep 14, 1977

ADAPTER A-413

K771642 · DTD

Cardiovascular · 16d

Cleared Dec 23, 1976

LITHIUM IODIDE BATTERY PACEMAKER (#201)

K761143 · DXY

Cardiovascular · 27d

Cleared Nov 11, 1976

MODEL 100 CARDIAC PACEMAKER

K760757 · DXY

Cardiovascular · 41d