Home / 510(k) Clearances / K810928

510(k) K810928

ENDOCARDIAL ELECTRODE by Vitatron Medical BV — Product Code DTB

K810928 is an FDA 510(k) premarket notification submitted by Vitatron Medical BV for the device "ENDOCARDIAL ELECTRODE". The FDA issued a decision of Substantially Equivalent on July 2, 1981. The device falls under product code DTB (Permanent Pacemaker Electrode), a Class III device regulated under 21 CFR 870.3680. Vitatron Medical BV has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 2, 1981
Date Received
April 6, 1981
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 Vitatron Medical BV

  • K854790 — CERYX PACEMAKER MODELS 114, 314 & 614 (August 28, 1986)
  • K844484 — HEWLETT PACKARDT HP 85 W/ VITATRON PH1 PROGRAM HEA (July 24, 1985)
  • K844483 — TP 1 (April 19, 1985)
  • K844485 — CERYX6, 611, CERYX 3 311 & CERYX 1 111 (April 19, 1985)
  • K840668 — ELECTRODE PACEMAKER, PERM & TEMP (September 24, 1984)
  • K831860 — GENERATOR, PULSE, PACEMAKER #532 (October 27, 1983)
  • K831859 — PACEMAKER PROGRAMMER #2032 (October 27, 1983)
  • K791920 — CARDIAC PACEMAKER P4000 SER. & P1000 (November 29, 1979)
  • K791921 — CARDIAC PACEMAKER C4000, C1000 SER. (October 26, 1979)
  • K791380 — VA 1000 (September 19, 1979)

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