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510(k) K861422

PACESETTER/SIEMENS PULSE GENERA W/VS-1 HEAD CAVITY by Pacesetter Systems — Product Code DXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 26, 1986
Date Received
April 16, 1986
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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  • K900512 — SIEMENS ELEMA MODELS 4020T AND 4021T ADAPTERS (June 25, 1990)
  • K900550 — FAST-PASS ACE MODELS 1212T/1222T/1216T/1226T (April 20, 1990)
  • K895447 — ENDOCARDIAL SCREW-IN LEAD MODEL 1020T (December 20, 1989)
  • K891905 — CARDIOVASCULAR PERMANENT PACEMAKER ELECTRODE (June 5, 1989)
  • K885267 — VS-1 MODEL NUMBER 251K PULSE GENERATOR (March 28, 1989)
  • K890547 — SIEMENS ELEMA MODELS 4025 AND 4026 ADAPTERS (March 22, 1989)
  • K884733 — AFP MODEL 262T PULSE GENERATOR (February 10, 1989)
  • K883087 — PROLOG MP 658M PULSE GENERATOR (September 14, 1988)

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)