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510(k) K863046

ULTRA SOFTWARE MODULE: MODEL 2016 by Cardiac Pacemakers, Inc. — Product Code KRG

K863046 is an FDA 510(k) premarket notification submitted by Cardiac Pacemakers, Inc. for the device "ULTRA SOFTWARE MODULE: MODEL 2016". The FDA issued a decision of Substantially Equivalent on December 5, 1986. The device falls under product code KRG (Programmer, Pacemaker), a Class III device regulated under 21 CFR 870.3700. Cardiac Pacemakers, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 5, 1986
Date Received
August 12, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Programmer, Pacemaker
Device Class
Class III
Regulation Number
870.3700
Review Panel
CV
Submission Type

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)

Other clearances for product code KRG

  • K933278 — INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04 (March 15, 1995)
  • K884522 — MODEL 5650 OPTIMATE PERSONAL PROGRAMMER (August 25, 1989)
  • K880738 — MODEL 2331T PATIENT PROGRAMMER (November 17, 1988)
  • K882429 — MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004 (July 22, 1988)
  • K864712 — MODEL 1740 PERSONAL POCKET PROGRAMMER (December 17, 1987)
  • K871986 — MODEL 5600B PROGRAMMER, PACEMAKER (June 24, 1987)
  • K863045 — PROGRAMMER MODEL 2035/ELECTROGRAM CABLE MODEL 6580 (September 29, 1986)
  • K860584 — SOFTWARE MODULE/2035 PROG AND ASTRA/T PULSE GEN (June 6, 1986)
  • K860546 — DIALOG PROGRAMMER 700 - PROGRAM VERSION 6.37 (April 23, 1986)
  • K844484 — HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA (July 24, 1985)

FDA data resources