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510(k) K926340

NEW LEAD INTRODUCER KITS, VARIOUS MODELS by Telectronics Pacing Systems, Inc. — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 27, 1993
Date Received
December 17, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Introducer, Catheter
Device Class
Class II
Regulation Number
870.1340
Review Panel
CV
Submission Type

Other clearances by Telectronics Pacing Systems, Inc.

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  • K943657 — STERILIZATION (June 24, 1996)
  • K934899 — BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM (May 12, 1994)
  • K914489 — NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING (August 17, 1992)
  • 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)

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