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510(k) K894494

LABELING CHANGES TO PULSE GENE. & PULSE GENE. LEAD by Biotronik, GmbH & Co. — Product Code DXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1989
Date Received
July 19, 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

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  • K914109 — PIKOS 01 & PIKOS E 01 (February 26, 1992)
  • K910609 — PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIP (August 28, 1991)
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  • 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)

Other clearances for product code DXY

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  • 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)