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510(k) K822857

CPI PRINTER by Cardiac Pacemakers, Inc. — Product Code KAG

K822857 is an FDA 510(k) premarket notification submitted by Cardiac Pacemakers, Inc. for the device "CPI PRINTER". The FDA issued a decision of Substantially Equivalent on January 8, 1983. The device falls under product code KAG (Holder, Speculum, Ent), a Class I device regulated under 21 CFR 878.1800. Cardiac Pacemakers, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 8, 1983
Date Received
September 27, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Holder, Speculum, Ent
Device Class
Class I
Regulation Number
878.1800
Review Panel
SU
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 KAG

  • K842931 — DRABKIN REAGENT (September 21, 1984)

FDA data resources