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510(k) K895110

MAESTRO PACEMAKER TEST MAGNET by Cardiac Control Systems, Inc. — Product Code DTG

K895110 is an FDA 510(k) premarket notification submitted by Cardiac Control Systems, Inc. for the device "MAESTRO PACEMAKER TEST MAGNET". The FDA issued a decision of Substantially Equivalent on September 26, 1989. The device falls under product code DTG (Magnet, Test, Pacemaker), a Class I device regulated under 21 CFR 870.3690. Cardiac Control Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 26, 1989
Date Received
August 15, 1989
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Magnet, Test, Pacemaker
Device Class
Class I
Regulation Number
870.3690
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)
  • 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)
  • K883016 — POLYSAFE IMPLANT. PACING LEADS W/TINED FIXA. TIP (September 16, 1988)

Other clearances for product code DTG

  • K092364 — MODEL 220 PATIENT MAGNET (November 3, 2009)
  • K960849 — MAGNO ALARM (March 26, 1997)
  • K831926 — IMPLANTABLE ENDOCARDIAL PACING LEADS (March 12, 1984)
  • K813153 — TEST MAGNET (December 2, 1981)

FDA data resources