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510(k) K864153

PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL 3290 by Pace Medical — Product Code DTB

K864153 is an FDA 510(k) premarket notification submitted by Pace Medical for the device "PACE IMPLANT. LEAD/TINED/ATRIAL/J/MODEL 3290". 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. Pace Medical has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 6, 1987
Date Received
October 23, 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 Pace Medical

  • K011980 — ADAPTER, PACING ANALYZER/UNIVERSAL PACING ADAPTER, MODELS 4820 AND 4825 (September 12, 2001)
  • K012392 — DISPOSABLE SURGICAL EXTENSION CABLE, MODEL 4255 AND MODEL 4260 (September 4, 2001)
  • K002204 — PACEMAKER EXTENSION CABLE MODELS 4265,4265A, 4265V, 5265, 5265A, 5265V (October 18, 2000)
  • K002496 — MODEL 4815 ADAPTER (October 10, 2000)
  • K002497 — MODEL 4810 ANALYZER OUTPUT ADAPTER (October 10, 2000)
  • K001180 — TEMPORARY PACEMAKER EXTENSION CABLE, MODELS 5235, 5235A, 5235V, TEMPORARY PACEMA (June 27, 2000)
  • K925143 — MODEL 4800 ACCUPACE PACING SYSTEM ANALYER (September 27, 1994)
  • K931662 — LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES (August 31, 1993)
  • K922899 — MODEL 4280 SURGICAL EXTENSION CABLE (December 23, 1992)
  • K913805 — MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER (November 19, 1991)

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