Medical Device Manufacturer · US , Irvine , CA

Passy-Muir, Inc. - FDA 510(k) Cleared Devices

5 submissions · 5 cleared · Since 1995

Recent clearances: Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15), PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT, PASSY-MUIR O2 ADAPTER

5

Total

5

Cleared

0

Denied

Passy-Muir, Inc. has 5 FDA 510(k) cleared medical devices. Based in Irvine, US.

Last cleared in 2023. Active since 1995. Primary specialty: Anesthesiology.

Browse the FDA 510(k) cleared devices submitted by Passy-Muir, Inc. Filter by specialty or product code using the sidebar.

Passy-Muir, Inc. is one of 16360 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.

FDA 510(k) Regulatory Record - Passy-Muir, Inc.

5 devices

1-5 of 5

Cleared Sep 16, 2023

Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)

General Hospital · 205d

Cleared Jun 11, 1999

PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT

Anesthesiology · 85d

Cleared Feb 12, 1997

PASSY-MUIR O2 ADAPTER

Anesthesiology · 12d

Cleared Oct 28, 1996

PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVE

Anesthesiology · 108d

Cleared Jul 07, 1995

PASSY-MUIR TRACHEOSTOMY SPEAKING VALVES (ONE-WAY TRACHEOSTOMY SPEAKING VALVES)

Anesthesiology · 298d