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510(k) K780470

H.P. MEDICAL GRADE SILICONE TUBING by Dow Corning Corp. Healthcare Industries Materials — Product Code KDL

K780470 is an FDA 510(k) premarket notification submitted by Dow Corning Corp. Healthcare Industries Materials for the device "H.P. MEDICAL GRADE SILICONE TUBING". The FDA issued a decision of Substantially Equivalent on April 27, 1978. The device falls under product code KDL (Set, Perfusion, Kidney, Disposable), a Class II device regulated under 21 CFR 876.5880. Dow Corning Corp. Healthcare Industries Materials has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 27, 1978
Date Received
March 22, 1978
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 Dow Corning Corp. Healthcare Industries Materials

  • K853186 — SILASTIC INFLATABLE BONE PLUG H.P. (September 24, 1985)
  • K844637 — WHITESIDE ACRYLIC CEMENT SPACER SLEEVE (June 19, 1985)
  • K850255 — DOW CORNING WRIGHT TITANIUM WRIST JOINT GROMMET (May 1, 1985)
  • K843995 — TF-II HIP PROSTHESIS (April 23, 1985)
  • K842559 — WHITESIDE ORTHOLOC TOTAL HIP FEMORAL (December 20, 1984)
  • K840357 — SSA HIP PROSTHESIS (February 17, 1984)
  • K831479 — METAL-BACKED ACETABULAR CUP (June 15, 1983)
  • K812864 — SILASTIC VOICE PROSTHESIS (November 24, 1981)
  • K812053 — SILASTIC HEMI WRIST IMPLANT H.P. (RAD.) (August 18, 1981)
  • K811679 — SILASTIC TENDON PASSER H.P. (July 10, 1981)

Other clearances for product code KDL

  • K241239 — OrganProtex HTK Solution (January 24, 2025)
  • K221386 — PERF-GEN Pulsatile Perfusion Solution (June 14, 2022)
  • K221387 — BEL-GEN Cold Storage 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