Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)— 510(k) K230483
Substantially EquivalentPassy-Muir, Inc.
FDA 510(k) clearance K230483 for Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15), Substantially Equivalent on 2023-09-16. Applicant: Passy-Muir, Inc.. Device class: 2.
Clearance details
- Applicant
- Passy-Muir, Inc.
- 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
- Irvine, CA, US
Recent devices under product code CAH
view allMore clearances from Passy-Muir, Inc.
view all- K990905 — PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT
- K970365 — PASSY-MUIR O2 ADAPTER; PMA2000
- K962714 — PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVE; PRODUCT NUMBER PMV 2000 OR PMTSV 2000
- K944451 — PASSY-MUIR TRACHEOSTOMY SPEAKING VALVES (ONE-WAY TRACHEOSTOMY SPEAKING VALVES)
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.