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510(k) K910609

PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIP by Biotronik, GmbH & Co. — Product Code DTB

K910609 is an FDA 510(k) premarket notification submitted by Biotronik, GmbH & Co. for the device "PERMANENT IMPLANTABLE JP ENDOCARDIAL LEADS W/TIP". The FDA issued a decision of Substantially Equivalent on August 28, 1991. The device falls under product code DTB (Permanent Pacemaker Electrode), a Class III device regulated under 21 CFR 870.3680. Biotronik, GmbH & Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 28, 1991
Date Received
February 12, 1991
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 Biotronik, GmbH & Co.

  • K000763 — PX 53/15-BP, MODEL 130 050 AND PX 60/15-BP, MODEL 130 051 (April 6, 2000)
  • K923406 — BIOSCOPE (September 22, 1993)
  • K923026 — PIKOS 01-A AND PIKOS E01-A IMPLANTABLE PACEMAKER (August 19, 1993)
  • K922742 — HPM 40 HEART PACEMAKER MONITOR (March 18, 1993)
  • K914109 — PIKOS 01 & PIKOS E 01 (February 26, 1992)
  • K911142 — LEAD TERMINAL PIN CAPS, VARIOUS MODELS (August 9, 1991)
  • K910608 — PERMANENT IMPLANTABLE FH ENDOCARDIAL LEADS W/TIP (July 30, 1991)
  • K905087 — TRIOS 02 (May 7, 1991)
  • K903928 — LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD DJP 53-UP (October 16, 1990)
  • K903927 — LABEL CHANGE UNIPOLAR ENDOCARDIAL LEAD, DJP 45-UP (October 16, 1990)

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