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510(k) K914109

PIKOS 01 & PIKOS E 01 by Biotronik, GmbH & Co. — Product Code DXY

K914109 is an FDA 510(k) premarket notification submitted by Biotronik, GmbH & Co. for the device "PIKOS 01 & PIKOS E 01". The FDA issued a decision of Substantially Equivalent on February 26, 1992. 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
February 26, 1992
Date Received
September 13, 1991
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)
  • K923026 — PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER (August 19, 1993)
  • K922742 — HPM 40 HEART PACEMAKER MONITOR (March 18, 1993)
  • 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)
  • K903929 — LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 60-UP (October 16, 1990)
  • K903928 — LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-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)
  • 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)
  • K950751 — TECOTHANE 75D POLYURETHANE RESIN FOR PULSE GENERATOR CONNECTOR MODULES (May 15, 1995)

FDA data resources