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510(k) K863000

ASTRA 2,3,4 AND 6: CHIP REVISION by Cardiac Pacemakers, Inc.

K863000 is an FDA 510(k) premarket notification submitted by Cardiac Pacemakers, Inc. for the device "ASTRA 2,3,4 AND 6: CHIP REVISION". The FDA issued a decision of Substantially Equivalent on August 19, 1986. Cardiac Pacemakers, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1986
Date Received
August 8, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Cardiac Pacemakers, Inc.

  • K093969 — ACUITY BREAK-AWAY GUIDE CATHETER (March 5, 2010)
  • K080154 — ACUITY UNIVERSAL CUTTER (March 20, 2008)
  • K934727 — REPLACEMENT PARTS FOR CPI 6888 LEAD TUNNELER (January 10, 1994)
  • K920601 — ASTRA T2, ASTRA T4, ASTRA T6 (October 28, 1992)
  • K912379 — PDT CARRYALL TRANSMITTER, VARIOUS MODELS (June 17, 1991)
  • K905674 — LEAD STYLET (January 30, 1991)
  • K900498 — MODIFIED BETATRON IV INSULIN INFUSION SYSTEM (February 23, 1990)
  • 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)

FDA data resources