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510(k) K800838

ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN. by Arco Medical Products Co. — Product Code DXY

K800838 is an FDA 510(k) premarket notification submitted by Arco Medical Products Co. for the device "ARCOLITH 3022&ARCOLITH 3023 CARDIAC GEN.". The FDA issued a decision of Substantially Equivalent on June 4, 1980. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Arco Medical Products Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1980
Date Received
April 15, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Implantable Pacemaker Pulse-Generator
Device Class
Class III
Regulation Number
870.3610
Review Panel
CV
Submission Type

Other clearances by Arco Medical Products Co.

  • K802588 — MODEL 3003 UNIPOLAR DEMAND CARDIAC GEN. (November 19, 1980)
  • K801806 — EXTERNAL SILASTIC BOOT FOR CARDIAC PULSE (September 9, 1980)
  • K801241 — UNIPOLAR PROGRAMMABLE LITHIUM CARD. GEN. (June 30, 1980)
  • K800837 — PROGRAMMABLE BIPOLAR CARDIAC GENERATOR (June 30, 1980)
  • K800326 — ARCOLITH 3021-CARDIAC PULSE GENERATOR (March 17, 1980)
  • K792299 — ARCOLITH 3020-CARDIAC PULSE GENERATOR (November 29, 1979)
  • K792216 — ARCOLITH 2100-CARDIAC PULSE GENERATOR (November 29, 1979)
  • K791715 — ARCOLITH 2000 (September 27, 1979)
  • K791147 — ARCO PROGAMMABLE PACEMAKER SYSTEM (August 3, 1979)
  • K791165 — ARCOLITH 4000 (July 10, 1979)

Other clearances for product code DXY

  • K993434 — PIKOS 01, PIKOS E01, PIKOS 01-B, PIKOS E01-B, PIKOS 01-A, PIKOS E01-A (November 10, 1999)
  • K970072 — OPUS S MODEL 4121 AND 4124 PACEMAKERS (August 29, 1997)
  • K945627 — PIKOS LP 01, PIKOS LP E01 (March 4, 1996)
  • K953866 — MINIX 834M & MINIX ST 8331M PULSE GENERATORS (MODIFICATION) (December 15, 1995)
  • K954092 — ALTERNATE STERLIZATION PROCESS & MODIFIED DF-1 LEAD CONNECTOR (MODIFICATION) (December 15, 1995)
  • K952328 — NANOS, PIKOS 01/E01, 01-A, E01-B, LP 01/LP E01 (September 29, 1995)
  • K953417 — MINIFLEX MODEL 340, 341, AND 342 PULSE GENERATORS (September 29, 1995)
  • K952364 — OPUS PACEMAKERS (MODELS 4001, 4003, 4004, 4023, 4024) (September 1, 1995)
  • K940039 — PELLETHANE 75D (July 12, 1995)
  • K946188 — CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER (May 15, 1995)

FDA data resources