Venticis II
FDA 510(k) K863778 · Cis-Us, Inc.
510(k) numberK863778
Submission
- Device name
- Venticis II
- Applicant
- Cis-Us, Inc.
Lake Success, NY, US - Received
- September 26, 1986
- Decision date
- October 27, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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| K253942 | Pulmonex II Xenon System (132-503)IYT · Traditional | Mirion Technologies (Capintec), Inc. | 07/07/2026SE |
| K200916 | Patient Administration SetIYT · Traditional | Cyclomedica Australia Pty, Ltd. | 09/01/2020SE |
| K953513 | Xenon CircuitIYT · Traditional | King Systems Corp. | 11/03/1995SE |
| K952223 | Xenon Gas Breathing CircuitIYT · Traditional | Intertech Resources, Inc. | 08/11/1995SE |
| K914747 | Xenon CircuitIYT · Traditional | Gibeck, Inc. | 02/27/1992SE |
| K913416 | Tetley Patient Administration SetIYT · Traditional | Tetley Medical , Ltd. | 10/28/1991SE |
| K912626 | Bolus Xenon CircuitIYT · Traditional | Vital Signs, Inc. | 08/02/1991SE |
| K904684 | Amici Krypton Administration System, ModificationIYT · Traditional | Amici, Inc. | 01/14/1991SE |
| K903805 | Amici Xenon Administration SetIYT · Traditional | Amici, Inc. | 01/14/1991SE |
| K903694 | Amici Tru-Fit Soft Plastic MouthpieceIYT · Traditional | Amici, Inc. | 10/03/1990SE |
More from Amici, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K951708 | Elsa-HctJKR · Traditional | 09/05/1995SE |
| K950211 | Elsa-PthCEW · Traditional | 04/13/1995SE |
| K890799 | Curietron 192 High Dose RateJAQ · Traditional | 10/27/1989SE |
| K882449 | Cesium 137 Source, Model CSM-40IWI · Traditional | 04/14/1989SE |
| K871502 | Personnel Protective ShieldKPY · Traditional | 05/08/1987SE |
| K865027 | Irradiator for Biological Materials, IBL-137CMOT · Traditional | 02/26/1987SE |
| K860823 | Elsa-Prol Immunoradiometric Assay KitCFT · Traditional | 08/19/1986SE |
| K860824 | Tshk-Nn Ria KitJLW · Traditional | 04/28/1986SE |
Questions and answers
When was Venticis II cleared by the FDA?
Venticis II (K863778) received a 510(k) decision of Substantially Equivalent on October 27, 1986, 31 days after the submission was received.
What is the product code of K863778?
The FDA product code is IYT – System, Rebreathing, Radionuclide, a Class II (moderate risk) device regulated under 21 CFR 892.1390.