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510(k) K931662

LEAD INTRODUCER SET, VARIOUS MODELS AND SIZES by Pace Medical — Product Code DYB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1993
Date Received
April 5, 1993
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 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)
  • K922899 — MODEL 4280 SURGICAL EXTENSION CABLE (December 23, 1992)
  • K913805 — MINIATURE MODELS 4562/4563/4572/4573 PACEMAKER (November 19, 1991)
  • K913134 — MODEL 4220 (August 22, 1991)

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