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510(k) K884411

OPTIMA MPT AND SPT PACEMAKERS by Telectronics, Inc. — Product Code DXY

K884411 is an FDA 510(k) premarket notification submitted by Telectronics, Inc. for the device "OPTIMA MPT AND SPT PACEMAKERS". The FDA issued a decision of Substantially Equivalent on January 26, 1989. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Telectronics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 26, 1989
Date Received
October 20, 1988
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, Inc.

  • K890895 — IMPLANTABLE ADAPTOR 033-380 (March 6, 1990)
  • K891231 — OPTIMA MPT AND SPT PACEMAKERS (September 12, 1989)
  • K890350 — VS-1 SILICONE IMPLANT LEADS (NEW SERIAL # TUBE) (February 2, 1989)
  • K884278 — IMPLANTABLE ELECTRODE LEADS 033-400,402 AND 436 (December 15, 1988)
  • K881837 — OPTIMA MPT SERIES III PACEMAKER, 5281D AND 5282D (July 18, 1988)
  • K874664 — IMPLANTABLE ELECTRODE LEAD, MODEL 030-446 (May 31, 1988)
  • K864712 — MODEL 1740 PERSONAL POCKET PROGRAMMER (December 17, 1987)
  • K872766 — IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS (November 4, 1987)
  • K865098 — SLIMLINE UNIPOLAR ENDOCARDIAL PACING LEAD, 030-438 (August 18, 1987)
  • K871992 — IMPLANTABLE PROGRAMMABLE CARDIAC PULSE GENERATORS (August 12, 1987)

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)
  • K953866 — MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION) (December 15, 1995)
  • K954092 — ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION) (December 15, 1995)
  • K952328 — NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01 (September 29, 1995)
  • K953417 — MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS (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)

FDA data resources