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510(k) K864601

CCS POLYSAFE(TM) ENDOCARDIAL PACING LEAD by Cardiac Control Systems, Inc. — Product Code DTB

K864601 is an FDA 510(k) premarket notification submitted by Cardiac Control Systems, Inc. for the device "CCS POLYSAFE(TM) ENDOCARDIAL PACING LEAD". The FDA issued a decision of Substantially Equivalent on January 6, 1987. The device falls under product code DTB (Permanent Pacemaker Electrode), a Class III device regulated under 21 CFR 870.3680. Cardiac Control Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 1987
Date Received
November 24, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Permanent Pacemaker Electrode
Device Class
Class III
Regulation Number
870.3680
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 DTB

  • K061212 — BIOTRONIK ENDOCARDIAL PACING LEADS (July 10, 2006)
  • K041809 — PERMANENT PACING LEAD, MODEL PY2 (August 6, 2004)
  • K040569 — PERMANENT PACING LEAD, MODEL REFINO, MODEL: REFINO-R, RU, RJU (April 7, 2004)
  • K031274 — MODEL 5071 MYOCARDIAL PACING LEAD (May 22, 2003)
  • K031210 — MODEL 4951M MYOCARDIAL UNIPOLAR LEAD (May 16, 2003)
  • K023205 — ELOX P 45-BP; ELOX P 53-BP; ELOX P 60-BP (April 24, 2003)
  • K024053 — PERMANENT PACING LEADS, MODELS PHYSIQUE PB AND PJB (January 31, 2003)
  • K023803 — MODIFICATION TO BIOTRONIK'S STERILIZATION PROCESS (December 11, 2002)
  • K023099 — AROX 45-JBP; AROX 53-JBP; MEROX 45-JBP; MEROX 53-JBP (October 18, 2002)
  • K021217 — AROX 53-BP; AROX 60-BP; AROX 45-JBP; AROX 53-JBP (May 1, 2002)

FDA data resources