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510(k) K760922

PERFUSION TUBING SET by Shiley, Inc. — Product Code KDL

K760922 is an FDA 510(k) premarket notification submitted by Shiley, Inc. for the device "PERFUSION TUBING SET". The FDA issued a decision of Substantially Equivalent on November 19, 1976. The device falls under product code KDL (Set, Perfusion, Kidney, Disposable), a Class II device regulated under 21 CFR 876.5880. Shiley, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 1976
Date Received
October 28, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Perfusion, Kidney, Disposable
Device Class
Class II
Regulation Number
876.5880
Review Panel
GU
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)
  • K901250 — PLEXUS 2(TM) INFANT HOLLOW FIBER OXYGENATOR (June 11, 1990)
  • K901249 — PLEXUS 3.5(TM) PEDIATRIC HOLLOW FIBER OXYGENATOR (June 11, 1990)
  • K900797 — STOCKERT SHILEY DUAL PRESSURE CONTROL MODULE XR (May 10, 1990)

Other clearances for product code KDL

  • K241239 — OrganProtex HTK Solution (January 24, 2025)
  • K221387 — BEL-GEN Cold Storage Solution (June 14, 2022)
  • K221386 — PERF-GEN Pulsatile Perfusion Solution (June 14, 2022)
  • K211842 — Servator M SALF Solution (December 20, 2021)
  • K192408 — Custodiol HTK Solution (April 24, 2020)
  • K170150 — Servator H SALF solution-1000 ml PVC free bags, Servator H SALF solution-2000 ml (October 20, 2017)
  • K121736 — PERF-GEN PULSATILE PERFUSION SOLUTION (August 16, 2013)
  • K121618 — BEL-GEN COLD STORAGE SOLUTION (June 14, 2013)
  • K091656 — SPS-1TM STATIC PRESERVATION SOLUTION, MODELS SPS-1-500 ML, SPS 1-1L, SPS-1-2L (March 11, 2010)
  • K043461 — CUSTODIOL (February 28, 2005)

FDA data resources