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510(k) K842369

ELECATH INFANT ARTERIAL & VENOUS CANNU by Electro-Catheter Corp. — Product Code BWF

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 27, 1984
Date Received
June 15, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Spirometer, Therapeutic (Incentive)
Device Class
Class II
Regulation Number
868.5690
Review Panel
AN
Submission Type

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  • K933450 — CLOSED 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)

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