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510(k) K882429

MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004 by Tpl-Cordis, Inc. — Product Code KRG

K882429 is an FDA 510(k) premarket notification submitted by Tpl-Cordis, Inc. for the device "MODEL 255A PROGRAMMER III, W/SOFTWARE REVI. 4004". The FDA issued a decision of Substantially Equivalent on July 22, 1988. The device falls under product code KRG (Programmer, Pacemaker), a Class III device regulated under 21 CFR 870.3700. Tpl-Cordis, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 22, 1988
Date Received
June 14, 1988
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 Tpl-Cordis, Inc.

  • K885240 — MODIFIED ANCOR & HI-FLEX UNIPOLAR ACTIVE FIX. LEAD (February 10, 1989)
  • K880898 — MULTICOR AND PACEMAKERS (May 6, 1988)
  • K880432 — VICOR PACER, MODEL 410A (February 22, 1988)
  • K873158 — MODIFIED MULTICOR AND OMNI-STANICOR PACEMAKERS (January 7, 1988)
  • K873202 — VICOR, MODEL 410A (October 15, 1987)

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)
  • K864712 — MODEL 1740 PERSONAL POCKET PROGRAMMER (December 17, 1987)
  • K871986 — MODEL 5600B PROGRAMMER, PACEMAKER (June 24, 1987)
  • K863046 — ULTRA SOFTWARE MODULE: MODEL 2016 (December 5, 1986)
  • 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