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510(k) K790503

CARDIOTEST 2200 by Cardiac Pacemakers, Inc. — Product Code DTA

K790503 is an FDA 510(k) premarket notification submitted by Cardiac Pacemakers, Inc. for the device "CARDIOTEST 2200". The FDA issued a decision of Substantially Equivalent on May 17, 1979. The device falls under product code DTA (Tester, Pacemaker Electrode Function), a Class II device regulated under 21 CFR 870.3720. Cardiac Pacemakers, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 17, 1979
Date Received
March 13, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tester, Pacemaker Electrode Function
Device Class
Class II
Regulation Number
870.3720
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 DTA

  • K163008 — CareLink SmartSync Device Manager - Pacing System Analyzer (February 28, 2017)
  • K101982 — MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180 (December 21, 2010)
  • K073230 — MODELS ERA 300 AND 3105 PACING SYSTEM ANALYZERS (December 20, 2007)
  • K050884 — ADAPTER CABLE (May 19, 2005)
  • K033613 — MODIFICATION TO ERA 300 DUAL CHAMBER PACING SYSTEM ANALYZER (December 8, 2003)
  • K022360 — ERA 3000; PA-2 IS-1 ADAPTER; EK-4-N PACEMAKER TEST CABLE; ERA 3000 CHARGER; ERA (January 27, 2003)
  • K933069 — MODEL EP-2 CLINICAL STIMULATOR (October 21, 1993)
  • K812104 — SIEMENS-ELEMA PSA 376 (December 2, 1981)
  • K791380 — VA 1000 (September 19, 1979)

FDA data resources