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510(k) K897116

OPTIMA MPT MODEL 5281E AND MODEL 5282E by Telectronics Pacing Systems, Inc. — Product Code DXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 14, 1990
Date Received
December 26, 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 Telectronics Pacing Systems, Inc.

  • K961118 — MAXIM PF MODELS 033-581/033-590 (July 15, 1996)
  • K943657 — STERILIZATION (June 24, 1996)
  • K934899 — BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM (May 12, 1994)
  • K926340 — NEW LEAD INTRODUCER KITS, VARIOUS MODELS (May 27, 1993)
  • K914489 — NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING (August 17, 1992)
  • K913919 — UNIVERSAL TERMINAL CAP, 3.2MM (December 31, 1991)
  • K912773 — UNIPOLAR UPSIZING ADAPTOR (October 23, 1991)
  • K911273 — 100 CM PERMANENT PACING LEAD MODELS (August 28, 1991)
  • K910112 — BIFURCATED VS-1 TO VS-1 LEAD ADAPTOR (February 25, 1991)
  • K903186 — OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE (January 18, 1991)

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)