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510(k) K914489

NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING by Telectronics Pacing Systems, Inc. — Product Code DTB

K914489 is an FDA 510(k) premarket notification submitted by Telectronics Pacing Systems, Inc. for the device "NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING". The FDA issued a decision of Substantially Equivalent on August 17, 1992. The device falls under product code DTB (Permanent Pacemaker Electrode), a Class III device regulated under 21 CFR 870.3680. Telectronics Pacing Systems, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 17, 1992
Date Received
October 8, 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 Telectronics Pacing Systems, Inc.

  • K961118 — MAXIM PF MODELS 033-581/033-590 (July 15, 1996)
  • K943657 — STERILIZATION (June 24, 1996)
  • K934899 — BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM (May 12, 1994)
  • K926340 — NEW LEAD INTRODUCER KITS, VARIOUS MODELS (May 27, 1993)
  • K913919 — UNIVERSAL TERMINAL CAP, 3.2MM (December 31, 1991)
  • K912773 — UNIPOLAR UPSIZING ADAPTOR (October 23, 1991)
  • K911273 — 100 CM PERMANENT PACING LEAD MODELS (August 28, 1991)
  • K910112 — BIFURCATED VS-1 TO VS-1 LEAD ADAPTOR (February 25, 1991)
  • K903186 — OPTIMA SERIES II MODEL 147B SINGLE CHAMBER PULSE (January 18, 1991)
  • K904741 — LASERDISH POLY UNIPOLAR VENTRI LEAD W/TRAIL TINES (January 8, 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