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510(k) K863778

VENTICIS II by Cis-Us, Inc. — Product Code IYT

K863778 is an FDA 510(k) premarket notification submitted by Cis-Us, Inc. for the device "VENTICIS II". The FDA issued a decision of Substantially Equivalent on October 27, 1986. The device falls under product code IYT (System, Rebreathing, Radionuclide), a Class II device regulated under 21 CFR 892.1390. Cis-Us, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 27, 1986
Date Received
September 26, 1986
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Rebreathing, Radionuclide
Device Class
Class II
Regulation Number
892.1390
Review Panel
RA
Submission Type

Other clearances by Cis-Us, Inc.

  • K951708 — ELSA-HCT (September 5, 1995)
  • K950211 — ELSA-PTH (April 13, 1995)
  • K890799 — CURIETRON 192 HIGH DOSE RATE (October 27, 1989)
  • K882449 — CESIUM 137 SOURCE, MODEL CSM-40 (April 14, 1989)
  • K871502 — PERSONNEL PROTECTIVE SHIELD (May 8, 1987)
  • K865027 — IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C (February 26, 1987)
  • K860823 — ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT (August 19, 1986)
  • K860824 — TSHK-NN RIA KIT (April 28, 1986)

Other clearances for product code IYT

  • K253942 — Pulmonex II Xenon System (132-503) (July 7, 2026)
  • K200916 — Patient Administration Set (September 1, 2020)
  • K953513 — XENON CIRCUIT (November 3, 1995)
  • K952223 — XENON GAS BREATHING CIRCUIT (August 11, 1995)
  • K914747 — XENON CIRCUIT (February 27, 1992)
  • K913416 — TETLEY PATIENT ADMINISTRATION SET (October 28, 1991)
  • K912626 — BOLUS XENON CIRCUIT (August 2, 1991)
  • K904684 — AMICI KRYPTON ADMINISTRATION SYSTEM, MODIFICATION (January 14, 1991)
  • K903805 — AMICI XENON ADMINISTRATION SET (January 14, 1991)
  • K903694 — AMICI TRU-FIT SOFT PLASTIC MOUTHPIECE (October 3, 1990)

FDA data resources