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510(k) K894065

OPUS MODEL 4001 by Ela Medical, Inc. — Product Code DXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1989
Date Received
June 8, 1989
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 Ela Medical, Inc.

  • K042002 — SYNESCOPE, EASYSCOPE, SYNECOM, HOLTERREADER (October 20, 2004)
  • K032466 — SPIDERVIEW (August 22, 2003)
  • K002817 — SYNETEC (May 2, 2001)
  • K993448 — STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHA (April 10, 2000)
  • K000029 — STELA UT46 AND BT45/46 STRAIGHT TINED PACING LEADS, STELA UJ45 AND BJ44/45 J-SHA (April 4, 2000)
  • K990727 — SYNEFLASH & SYNEVIEW (November 26, 1999)
  • K972574 — STELA MODEL UJ45 PACING LEADS (January 8, 1998)
  • K970072 — OPUS S MODEL 4121 AND 4124 PACEMAKERS (August 29, 1997)
  • K963738 — STELA MODEL BJ44 AND BJ45 PACING LEADS (May 23, 1997)
  • K952364 — OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) (September 1, 1995)

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)