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510(k) K861009

BIPOLAR CARDIAC PACEMAKER, MODEL 110 by Cardiac Control Systems, Inc. — Product Code DXY

K861009 is an FDA 510(k) premarket notification submitted by Cardiac Control Systems, Inc. for the device "BIPOLAR CARDIAC PACEMAKER, MODEL 110". The FDA issued a decision of Substantially Equivalent on April 23, 1986. The device falls under product code DXY (Implantable Pacemaker Pulse-Generator), a Class III device regulated under 21 CFR 870.3610. Cardiac Control Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1986
Date Received
March 18, 1986
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 Cardiac Control Systems, Inc.

  • K971775 — INTERIM AV SHAPED TEMPORARY PACING CATHETER MODEL INT-AV610 (December 29, 1997)
  • K946188 — CCDS MAESTRO(R) II SERIES 200 CADIAC PACEMAKER (May 15, 1995)
  • K950210 — CCS MAESTRO(R) II SERIES 200 MODELS 235 AND 227 CARDIAC PACEMAKER (May 3, 1995)
  • K923868 — CCS MAESTRO II SERIES 200 CARDIAC PACEMAKER (May 14, 1993)
  • K905824 — MAESTRO(R) SERIES 100/200 CARDIAC S/CHAMB PACEMAKE (May 16, 1991)
  • K904941 — MAESTRO SERIES 100/200 CARDIAC SINGLE CHAMBER PACE (January 3, 1991)
  • K895110 — MAESTRO PACEMAKER TEST MAGNET (September 26, 1989)
  • K884023 — MAESTRO(R) SERIES 100/200 SINGLE CHAMBER PACEMAKER (October 17, 1988)
  • K884024 — POLYSAFE(TM) IMPLANTABLE PACING LEAD (October 14, 1988)
  • K883015 — POLYSAFE IMPLANT. PACING LEADS W/TRABECULOK TIP (October 6, 1988)

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