FDA Product Code DTB: Permanent Pacemaker Electrode

Cleared Oct 28, 1988

PERMANENT PACING LEADS PYBJ SERIES

K882345

Oscor Medical Corp.

Cardiovascular · 143d

Cleared Oct 28, 1988

PERMANENT PACING LEAD MODEL RXBJ SERIES

K882462

Oscor Medical Corp.

Cardiovascular · 135d

Cleared Oct 14, 1988

POLYSAFE(TM) IMPLANTABLE PACING LEAD

K884024

Cardiac Control Systems, Inc.

Cardiovascular · 22d

Cleared Oct 13, 1988

MEDTRONIC MODEL 4951P

K881810

Medtronic Vascular

Cardiovascular · 168d

Cleared Oct 06, 1988

POLYSAFE IMPLANT. PACING LEADS W/TRABECULOK TIP

K883015

Cardiac Control Systems, Inc.

Cardiovascular · 79d

Cleared Sep 16, 1988

POLYSAFE IMPLANT. PACING LEADS W/TINED FIXA. TIP

K883016

Cardiac Control Systems, Inc.

Cardiovascular · 59d

Cleared Sep 06, 1988

MODEL 5866-34A PACEMAKER LEAD ADAPTOR

K883203

Medtronic Vascular

Cardiovascular · 40d

Cleared Sep 06, 1988

BIOPORE VS.1 ENDOCARDIAL INTER IMPLANT PACING LEAD

K883602

Intermedics, Inc.

Cardiovascular · 14d

Cleared Aug 25, 1988

MEDTRONIC MODELS 4057/4557 ENDOCARDIAL PACING LEAD

K882452

Medtronic Vascular

Cardiovascular · 72d

Cleared May 31, 1988

IMPLANTABLE ELECTRODE LEAD, MODEL 030-446

K874664

Telectronics, Inc.

Cardiovascular · 200d

Cleared May 25, 1988

MODEL 435-04 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD

K875178

Intermedics, Inc.

Cardiovascular · 160d

Cleared May 25, 1988

MEDTRONIC MODEL 5866-36 LEAD ADAPTOR KIT

K881712

Medtronic Vascular

Cardiovascular · 34d

Cleared May 24, 1988

MODEL 438-03 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD

K875100

Intermedics, Inc.

Cardiovascular · 166d

Cleared Mar 22, 1988

MODEL 438-02 CARDIFIX SIDE HOOK IMPLANT. PACE LEAD

K872126

Intermedics, Inc.

Cardiovascular · 294d

Cleared Mar 07, 1988

MODEL 439-07 AND 439-09 LIFELINE MYOCARDIAL LEAD

K880551

Intermedics, Inc.

Cardiovascular · 27d

Cleared Feb 18, 1988

NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR

K875199

Biotronik Sales, Inc.

Cardiovascular · 62d

Cleared Feb 12, 1988

PERMANENT MYOCARDIAL LEADS MP SERIES

K872971

Oscor Medical Corp.

Cardiovascular · 198d

Cleared Feb 02, 1988

MEDTRONIC MODEL 4016A ENDOCARDIAL PACING LEAD

K873962

Medtronic Vascular

Cardiovascular · 126d

Cleared Feb 02, 1988

ENDOCARDIAL SCREW-IN LEAD, MODEL 1018T

K874205

Pacesetter Systems

Cardiovascular · 110d

Cleared Jan 29, 1988

ACTIFIX (R) BIPOLAR ENDOCARDIAL SCREW-IN LEAD

K874183

Daig Corp.

Cardiovascular · 108d

Cleared Jan 19, 1988

PACING LEADS MODEL 3262VU/VB, 3362VU/VB, 3380/3390

K874743

Pace Medical

Cardiovascular · 62d

Cleared Jan 19, 1988

MODEL 5013 TRANSVENOUS VENTRICULAR PACING LEAD

K874792

Medtronic Vascular

Cardiovascular · 60d

Cleared Jan 07, 1988

POLYFLEX(R) EPICARDIAL 439-04 IMPLANT PACING LEAD

K874531

Intermedics, Inc.

Cardiovascular · 65d

Cleared Jan 06, 1988

MODEL 366-12 ADAPTAID(TM) STEP-DOWN ADAPTER

K874930

Intermedics, Inc.

Cardiovascular · 35d