Breathing circuit bacterial/viral filter— 510(k) K222917
Substantially EquivalentShaoxing Haitech Medical Products Co., Ltd.
FDA 510(k) clearance K222917 for Breathing circuit bacterial/viral filter, Substantially Equivalent on 2024-02-15. Applicant: Shaoxing Haitech Medical Products Co., Ltd.. Device class: 2.
Clearance details
- Applicant
- Shaoxing Haitech Medical Products Co., Ltd.
- Product code
- Code CAH
- Device class
- Class 2
- Regulation
- 21 CFR 868.5260
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Shaoxing, CN
Recent devices under product code CAH
view all- K252643 — Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled
- K251583 — Ambu® Virobac II® Exhalation Filter
- K241339 — Besmed Bacterial Filter and HMEF
- K230483 — Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)
- K223258 — TNI Clear-Guard 3 angled breathing filter (1545020)
Adverse events under product code CAH
product code CAH- Death
- 7
- Total
- 7
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.