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510(k) K875199

NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR by Biotronik Sales, Inc. — Product Code DTB

K875199 is an FDA 510(k) premarket notification submitted by Biotronik Sales, Inc. for the device "NP BIPOLAR ENDOCARDIAL LEAD W/VS-1 CONNECTOR". The FDA issued a decision of Substantially Equivalent on February 18, 1988. 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
February 18, 1988
Date Received
December 18, 1987
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.

  • 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)
  • K853568 — DNR UNIPOLAR (January 15, 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