Home / 510(k) Clearances / K812813

510(k) K812813

INTERMEDICS PROGRAMMER, MODEL 522-03 by Intermedics, Inc. — Product Code KRG

K812813 is an FDA 510(k) premarket notification submitted by Intermedics, Inc. for the device "INTERMEDICS PROGRAMMER, MODEL 522-03". The FDA issued a decision of Substantially Equivalent on October 27, 1981. The device falls under product code KRG (Programmer, Pacemaker), a Class III device regulated under 21 CFR 870.3700. Intermedics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1981
Date Received
October 6, 1981
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 Intermedics, Inc.

  • K954610 — MODEL 430-07 ENDOCARDIAL PACING LEAD (December 16, 1996)
  • K955122 — INTERMEDICS MODEL 436-07 BIPOLAR & MODEL 437-07 UNIPOLAR IMPLANTABLE ENDOCARDIAL (November 4, 1996)
  • K962174 — BIPLR IM EN PAC LEADS (430-07,432-03,436-02 & 07, 438-05 & 07) (August 21, 1996)
  • K955550 — CARDIFIX EZ BIPOLAR/UNIPOLAR ENDOCARDIAL PACING LEAD (June 19, 1996)
  • K960281 — IMPLANTABLE PACING LEADS/IMPLANTABLE ACCESSORY/NON-IMPLANTABLE ACCESSORY (June 18, 1996)
  • K954719 — INTERMEDICS MODEL 430-07 BIPOLAR IMPLANTABLE ENDOCARDIAL PACING LEAD (February 27, 1996)
  • K933278 — INTERMEDICS TRIANGLE CHEST PROBE MODEL 526-04 (March 15, 1995)
  • K922042 — CARDIFIX ENDOCARDIAL PACING LEAD (April 29, 1993)
  • K922972 — MODELS 438-05 AND 435-05 IMPLANTABLE PACING LEAD (January 22, 1993)
  • K920530 — INTERMEDICS MODEL 366-15 VS 1 HEADER PLUG (March 17, 1992)

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)
  • 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)

FDA data resources