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510(k) K842394

ASTRA 2, ASTRA 3, 4 & 6 by Cardiac Pacemakers, Inc. — Product Code DXY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1984
Date Received
June 19, 1984
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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  • K894738 — MODEL 6888 LEAD TUNNELER (September 13, 1989)
  • K890785 — ASTRA T2, T3, T4, T6 PULSE GENERATORS NEW PACKAGE (March 10, 1989)
  • K875147 — TORQUE HEX WRENCH (January 27, 1988)

Other clearances for product code DXY

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  • 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)