Ventilator Tube with Filter
FDA 510(k) K791773 · Pharmaseal Div., Baxter Healthcare Corp.
510(k) numberK791773
Submission
- Device name
- Ventilator Tube with Filter
- Applicant
- Pharmaseal Div., Baxter Healthcare Corp.
Mchenry, IL, US - Received
- September 10, 1979
- Decision date
- October 22, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CAH – Filter, Bacterial, Breathing-Circuit
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5260
- Specialty
- Anesthesiology
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|---|---|---|---|
| K252643 | Iso-Gard Filter Straight; Humid-Vent Filter Compact AngledCAH · Traditional | Teleflex Medical Sdn. Bhd. | 05/15/2026SE |
| K251583 | Ambu® Virobac II® Exhalation FilterCAH · Traditional | Ambu A/S | 04/30/2026SE |
| K241339 | Besmed Bacterial Filter and HMEFCAH · Traditional | Besmed Health Business Corp | 11/14/2024SE |
| K222917 | Breathing circuit bacterial/viral filterCAH · Traditional | Shaoxing Haitech Medical Products Co., Ltd. | 02/15/2024SE |
| K230483 | Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)CAH · Traditional | Passy-Muir, Inc. | 09/16/2023SE |
| K223258 | TNI Clear-Guard 3 angled breathing filter (1545020)CAH · Traditional | Intersurgical , Ltd. | 06/15/2023SE |
| K221472 | Filter and HME/FilterCAH · Traditional | Ningbo Huakun Medical Equipment Co., Ltd. | 02/08/2023SE |
| K221836 | Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar PlusCAH · Traditional | Drägerwerk AG & Co. KGaA | 12/07/2022SE |
| K221250 | EasyOne FilterCAH · Traditional | Ndd Medizintechnik AG | 11/22/2022SE |
| K210352 | GGM Breathing Circuit Bacterial FilterCAH · Traditional | Great Group Medical Co, Ltd. | 03/27/2022SE |
More from Great Group Medical Co, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K792369 | Hyperalimentation Dressing TrayFRG · Traditional | 12/10/1979SE |
| K792141 | Continuous Flush DeviceKRA · Traditional | 12/05/1979SE |
| K792019 | Phadecode Xa Inhibitor AssayJBQ · Traditional | 11/05/1979SE |
| K791156 | Amipaque Myelogram TrayFMI · Traditional | 07/30/1979SE |
| K790896 | Two-Way Anesthesia FilterCAH · Traditional | 06/05/1979SE |
| K790409 | Low Dead Space Insulin SyringeFMF · Traditional | 04/24/1979SE |
| K782069 | Tray, Auxillary BlockCAZ · Traditional | 01/04/1979SE |
| K781797 | Prep Tray, Preoperative SkinOJU · Traditional | 11/08/1978SE |
| K781680 | Monitoring, Pressure KitDRS · Traditional | 10/06/1978SE |
| K780887 | Improved Disposable Hypodermic NeedleGAA · Traditional | 06/22/1978SE |
Questions and answers
When was Ventilator Tube with Filter cleared by the FDA?
Ventilator Tube with Filter (K791773) received a 510(k) decision of Substantially Equivalent on October 22, 1979, 42 days after the submission was received.
What is the product code of K791773?
The FDA product code is CAH – Filter, Bacterial, Breathing-Circuit, a Class II (moderate risk) device regulated under 21 CFR 868.5260.