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510(k) K901250

PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR by Shiley, Inc. — Product Code DTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 11, 1990
Date Received
March 16, 1990
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Oxygenator, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4350
Review Panel
CV
Submission Type

Other clearances by Shiley, Inc.

  • K920594 — SHILEY PERFUSION TUBING SETS (March 18, 1993)
  • K910991 — SHILEY THERAPEUTIC AUTOTRANSFUSION SYSTEM (November 27, 1991)
  • K911876 — SHILEY PLEXUS(R) VENOUS RESERVOIR, PVR1200 (August 9, 1991)
  • K910923 — BCD ADVANCED (April 9, 1991)
  • K901548 — BIOMEDICAL SENSORS-SHILEY BGM 4000 INTRA BLOOD GAS (January 14, 1991)
  • K903435 — SHILEY SPECIALIZED TRACHEOSTOMY TUBE (October 2, 1990)
  • K901624 — SHILEY PLEXUS INTEGRAL RESERVOIR HOLLOW FIBER OXY. (July 3, 1990)
  • K901249 — PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR (June 11, 1990)
  • K900797 — STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR (May 10, 1990)
  • K900548 — SHILEY PHONATION VALVE (April 23, 1990)

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