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510(k) K770720

TUBING PACK, EXTRACORPOREAL, H-3000 by William Harvey Life Products Corp. — Product Code BYS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1977
Date Received
April 18, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oxygenator, Long Term Support Greater Than 6 Hours
Device Class
Class II
Regulation Number
870.4100
Review Panel
CV
Submission Type

Other clearances by William Harvey Life Products Corp.

  • K811703 — CARDIFF ALDASORBER SYSTEM (June 16, 1981)
  • K810065 — SCOTT CM42 PASTEURIZER (January 28, 1981)

Other clearances for product code BYS

  • K232767 — Nautilus VF ECMO Oxygenator (October 4, 2023)
  • K191935 — Nautilus Smart ECMO Module (April 9, 2020)