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510(k) K854975

ELECATH PULSATILE PERFUSION PUMP by Electro-Catheter Corp. — Product Code KFM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 15, 1986
Date Received
December 12, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Device Class
Class II
Regulation Number
870.4360
Review Panel
CV
Submission Type

Other clearances by Electro-Catheter Corp.

  • K934785 — MULTIPACE (July 27, 1995)
  • K933451 — OPEN TIP MULTI-ELECTRODE CATHETER, MODIFICATION (April 19, 1995)
  • K933450 — CLOSED TIP MULTI-ELECTRODE CATHETER, MODIFICATION (April 19, 1995)
  • K943257 — TIP DEFLECTOR (GENESIS) (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)
  • 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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