Medical Device Manufacturer · US , Irvine , CA

Mallinckrodt Medical Tpi, Inc. - FDA 510(k) Cleared Devices

4 submissions · 4 cleared · Since 1993

4

Total

4

Cleared

0

Denied

FDA 510(k) Regulatory Record - Mallinckrodt Medical Tpi, Inc. Anesthesiology ✕

4 devices

1-4 of 4

Cleared Feb 27, 1995

SSV PHONATE(TM) SHILEY SPEAKING VALVE

Anesthesiology · 116d

Cleared Feb 27, 1995

SSVO PHONATE(TM) SHILEY SPEAKING VALVE WITH OXYGEN PORT

Anesthesiology · 116d

Cleared Aug 30, 1994

REUSABLE CANNULA TRACHEOSTOMY TUBES, MODIFIED HEADS

Anesthesiology · 266d

Cleared Jul 02, 1993

SHILEY FENESTRATED REUSABLE INNER CANNULA, MODIF

Anesthesiology · 130d