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510(k) K854511

ELECATH PERCUTANEOUS LEFT ATRIAL CANNULATION SET by Electro-Catheter Corp. — Product Code DQX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1986
Date Received
November 12, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wire, Guide, Catheter
Device Class
Class II
Regulation Number
870.1330
Review Panel
CV
Submission Type

Other clearances by Electro-Catheter Corp.

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  • 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)
  • 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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