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510(k) K860036

EDP-20 PACEMAKER by Biotronik Sales, Inc. — Product Code DXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 12, 1987
Date Received
January 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

Other clearances by Biotronik Sales, Inc.

  • K875199 — NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR (February 18, 1988)
  • K853194 — ERA-20 (March 11, 1987)
  • K863878 — TRIOS-M VS-1 PULSE GENERATOR (December 10, 1986)
  • K863879 — NEOS-M VS-1 PULSE GENERATOR (December 10, 1986)
  • K863480 — BIOTRONIK PERMANENT PACEMAKER ELECTRODE (September 23, 1986)
  • K860921 — NEOS VS-1, PULSE GENERATOR (August 8, 1986)
  • K860922 — MIKROS, MIKROS VS-1, PULSE GENERATOR (August 4, 1986)
  • K853566 — DJ UNIPOLAR (May 7, 1986)
  • K853567 — DJP UNIPOLAR (May 7, 1986)
  • K853568 — DNR UNIPOLAR (January 15, 1986)

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)