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510(k) K933450

CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATION by Electro-Catheter Corp. — Product Code DRF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 19, 1995
Date Received
July 12, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Electrode Recording, Or Probe, Electrode Recording
Device Class
Class II
Regulation Number
870.1220
Review Panel
CV
Submission Type

Other clearances by Electro-Catheter Corp.

  • K934785 — MULTIPACE (July 27, 1995)
  • K943257 — TIP DEFLECTOR (GENESIS) (April 19, 1995)
  • K933451 — OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATION (April 19, 1995)
  • K934787 — SILICORE SEMI-FLOATER (February 24, 1995)
  • K874154 — ELECATH(R) TRANSESOPHAGEAL PACING CATHETER (April 29, 1988)
  • K854511 — ELECATH PERCUTANEOUS LEFT ATRIAL CANNULATION SET (February 10, 1986)
  • K854975 — ELECATH PULSATILE PERFUSION PUMP (January 15, 1986)
  • K850065 — ELECATH TORKFLOAT PACING PROBE (April 10, 1985)
  • K850324 — ELECATH OPEN TIP BIPOLAR PACING CATHETER (March 27, 1985)
  • K844682 — ELECATH CARDIAC OUTPUT COMPUTER (March 6, 1985)

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