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510(k) K923026

PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER by Biotronik, GmbH & Co. — Product Code DXY

K923026 is an FDA 510(k) premarket notification submitted by Biotronik, GmbH & Co. for the device "PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER". The FDA issued a decision of Substantially Equivalent on August 19, 1993. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Biotronik, GmbH & Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1993
Date Received
June 23, 1992
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, GmbH & Co.

  • K000763 — PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051 (April 6, 2000)
  • K923406 — BIOSCOPE (September 22, 1993)
  • K922742 — HPM 40 HEART PACEMAKER MONITOR (March 18, 1993)
  • K914109 — PIKOS 01 & PIKOS E 01 (February 26, 1992)
  • K910609 — PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIP (August 28, 1991)
  • K911142 — LEAD TERMINAL PIN CAPS, VARIOUS MODELS (August 9, 1991)
  • K910608 — PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIP (July 30, 1991)
  • K905087 — TRIOS 02 (May 7, 1991)
  • K903928 — LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP (October 16, 1990)
  • K903927 — LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 45-UP (October 16, 1990)

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)
  • 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)

FDA data resources