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510(k) K791921

CARDIAC PACEMAKER C4000, C1000 SER. by Vitatron Medical BV — Product Code DXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 1979
Date Received
September 25, 1979
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 Vitatron Medical BV

  • K854790 — CERYX PACEMAKER MODELS 114, 314 & 614 (August 28, 1986)
  • K844484 — HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA (July 24, 1985)
  • K844485 — CERYX6, 611, CERYX 3 311 & CERYX 1 111 (April 19, 1985)
  • K844483 — TP 1 (April 19, 1985)
  • K840668 — ELECTRODE PACEMAKER, PERM & TEMP (September 24, 1984)
  • K831859 — PACEMAKER PROGRAMMER #2032 (October 27, 1983)
  • K831860 — GENERATOR, PULSE, PACEMAKER #532 (October 27, 1983)
  • K810928 — ENDOCARDIAL ELECTRODE (July 2, 1981)
  • K791920 — CARDIAC PACEMAKER P4000 SER. & P1000 (November 29, 1979)
  • K791380 — VA 1000 (September 19, 1979)

Other clearances for product code DXY

  • K993434 — PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A (November 10, 1999)
  • 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)