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510(k) K860466

MODEL 329D, SERIERS R BIOPOLAR CARDIAC PUL. GEN. by Cook Pacemaker Corp. — Product Code DXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1986
Date Received
February 6, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implantable Pacemaker Pulse-Generator
Device Class
Class III
Regulation Number
870.3610
Review Panel
CV
Submission Type

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  • K915188 — MODEL P IN-LINE BIPOLAR ENDOCARDIAL TINED LEAD (September 11, 1992)
  • K905403 — MODEL 340 SERIES UNIPOLAR & MODEL 5000B PROGRAMMER (October 16, 1991)
  • K863582 — MODEL 725TH HANDHELD TRANSCEIVER (PROGRAMMER) (October 8, 1986)
  • K861559 — SERIES (T) PROGRAMMABLE CARDIAC PULSE GENERATORS (May 9, 1986)
  • K860202 — MODEL 327D, SERIES R UNIPOLAR CARDIAC PULSE GENER. (February 24, 1986)
  • K854919 — BIPOLAR CARDIAC PULSE GENERATOR WITH TELEMETRY (December 19, 1985)
  • K854132 — COOK PACEMAKER 332T, SERIES R BIPOLAR CARDIAC PULS (December 3, 1985)

Other clearances for product code DXY

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  • K970072 — OPUS S MODEL 4121 AND 4124 PACEMAKERS (August 29, 1997)
  • K945627 — PIKOS LP 01, PIKOS LP E01 (March 4, 1996)
  • K954092 — ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION) (December 15, 1995)
  • K953866 — MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION) (December 15, 1995)
  • K953417 — MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS (September 29, 1995)
  • K952328 — NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01 (September 29, 1995)
  • K952364 — OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) (September 1, 1995)
  • K940039 — PELLETHANE 75D (July 12, 1995)
  • K946188 — CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER (May 15, 1995)