Atlas FDA

RUSCH AGT PVC PREF NASAL TRACH TUB/UNCUF W/MUR EYE

FDA 510(k) clearance K931165 · decided 1993-06-22

Clearance details

K-number
K931165
Device name
RUSCH AGT PVC PREF NASAL TRACH TUB/UNCUF W/MUR EYE
Applicant
Rusch, Inc.
Decision
Substantially Equivalent
Date received
1993-03-08
Decision date
1993-06-22
Days to decision
106 days
Clearance type
Traditional
Product code
BTR
Device class
2
Regulation number
868.5730
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Jeffrey, NH, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181030 recall (Z-1870-2023)TELEFLEX LLC2023-06-29
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181040 recall (Z-1871-2023)TELEFLEX LLC2023-06-29
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181045 recall (Z-1872-2023)TELEFLEX LLC2023-06-29
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181050 recall (Z-1873-2023)TELEFLEX LLC2023-06-29
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181055 recall (Z-1922-2023)TELEFLEX LLC2023-06-29
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181060 recall (Z-1923-2023)TELEFLEX LLC2023-06-29
Preformed AGT Oral Endotracheal Tube uncuffed/plain - Murphy, REF 100181065 recall (Z-1924-2023)TELEFLEX LLC2023-06-29