Home / 510(k) Clearances / K853568

510(k) K853568

DNR UNIPOLAR by Biotronik Sales, Inc. — Product Code DTB

K853568 is an FDA 510(k) premarket notification submitted by Biotronik Sales, Inc. for the device "DNR UNIPOLAR". The FDA issued a decision of Substantially Equivalent on January 15, 1986. The device falls under product code DTB (Permanent Pacemaker Electrode), a Class III device regulated under 21 CFR 870.3680. Biotronik Sales, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1986
Date Received
August 26, 1985
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 Sales, Inc.

  • K875199 — NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR (February 18, 1988)
  • K853194 — ERA-20 (March 11, 1987)
  • K860036 — EDP-20 PACEMAKER (January 12, 1987)
  • K863878 — TRIOS-M VS-1 PULSE GENERATOR (December 10, 1986)
  • K863879 — NEOS-M VS-1 PULSE GENERATOR (December 10, 1986)
  • K863480 — BIOTRONIK PERMANENT PACEMAKER ELECTRODE (September 23, 1986)
  • K860921 — NEOS VS-1, PULSE GENERATOR (August 8, 1986)
  • K860922 — MIKROS, MIKROS VS-1, PULSE GENERATOR (August 4, 1986)
  • K853567 — DJP UNIPOLAR (May 7, 1986)
  • K853566 — DJ UNIPOLAR (May 7, 1986)

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