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Cook Pacemaker Corp.

11 FDA 510(k) clearances · PMA applicant

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RecordFirmDate
KELVIN(R) MODEL 513 UNIPOLAR AND MODEL 514 BIPOLAR CARDIAC PULSE GENERATORS. (P870054/S014)Cook Pacemaker Corp.1995-07-12
MODEL K (UNIPOLAR) & M (BIPOLAR) ENDOCARDIAL LEADS (P870054/S009)Cook Pacemaker Corp.1990-10-31
MODEL Q (UNIPOLAR) & R (BIPOLAR) ENDOCARDIAL LEADS (P870054/S010)Cook Pacemaker Corp.1990-06-19
KELVIN (R) PACING SYSTEM (P870054/S011)Cook Pacemaker Corp.1990-03-19
KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR (P870054/S005)Cook Pacemaker Corp.1989-12-06
KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR (P870054/S003)Cook Pacemaker Corp.1989-09-19
KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR (P870054/S006)Cook Pacemaker Corp.1989-07-31
KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR (P870054/S004)Cook Pacemaker Corp.1989-06-20
KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR (P870054/S001)Cook Pacemaker Corp.1989-03-29
KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR (P870054/S002)Cook Pacemaker Corp.1989-03-22
KELVIN MODEL 500 UNIPOLAR CARDIAC PULSE GENERATOR (P870054)Cook Pacemaker Corp.1988-04-29

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Every clearance here is in the API, with alerts when new ones post.