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510(k) K900492

LABELING CHANGE - VIASPAN(TM) (BELZER UW) by The DU Pont Co. — Product Code KDL

K900492 is an FDA 510(k) premarket notification submitted by The DU Pont Co. for the device "LABELING CHANGE - VIASPAN(TM) (BELZER UW)". The FDA issued a decision of Substantially Equivalent on March 20, 1990. The device falls under product code KDL (Set, Perfusion, Kidney, Disposable), a Class II device regulated under 21 CFR 876.5880. The DU Pont Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1990
Date Received
February 2, 1990
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 The DU Pont Co.

  • K953477 — MODULAR DAYLIGHT CASSETTE FOR VIDEO IMAGING (October 7, 1995)
  • K953475 — CDS COMPACT DAYLIGHT CASSETTE FOR VIDEO IMAGING (October 7, 1995)
  • K952891 — CRONEX LOW ABSORPTION CASSETTE (July 13, 1995)
  • K945125 — DUPONT ACA VANCOMYCIN (VANC) METHOD (March 10, 1995)
  • K943704 — LIPASE CALIBRATOR (September 14, 1994)
  • K885258 — ACA THYROXINE (T4 E) METHOD (February 17, 1989)
  • K885259 — ACA THYRONINE UPTAKE (TU E) METHOD (February 17, 1989)
  • K884700 — ANALYST THYROXINE (T4) ROTOR (January 27, 1989)
  • K884169 — DU PONT ANALYST THYROID ROTOR (January 24, 1989)
  • K884168 — ANALYST THYROXINE (T4) & THYRONINE UPTAKE CALIBRA. (November 29, 1988)

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