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510(k) K913919

UNIVERSAL TERMINAL CAP, 3.2MM by Telectronics Pacing Systems, Inc. — Product Code KFJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 31, 1991
Date Received
September 3, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Materials, Repair Or Replacement, Pacemaker
Device Class
Class III
Regulation Number
870.3710
Review Panel
CV
Submission Type

Other clearances by Telectronics Pacing Systems, Inc.

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  • K934899 — BIFURCATED LEAD ADAPTORS, 3.2MM & 5.0 MM (May 12, 1994)
  • K926340 — NEW LEAD INTRODUCER KITS, VARIOUS MODELS (May 27, 1993)
  • K914489 — NEW EXTRUSION VENDOR FOR POLYURETHANE TUBING (August 17, 1992)
  • 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 KFJ

  • K852236 — MEDTRONIC MODEL 5867-1A (July 11, 1985)
  • K813518 — IMPLANT AID SPLICING CRIMP & SLEEVE (January 12, 1982)