Atlas FDA

MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBE

FDA 510(k) clearance K945513 · decided 1995-01-13

Clearance details

K-number
K945513
Device name
MALLINCKRODT SHILEY NEONATAL, PEDIATRIC, LONG PEDIATRIC TRACHEOSTOMY TUBE
Applicant
Mallinckrodt Medical
Decision
Substantially Equivalent
Date received
1994-11-09
Decision date
1995-01-13
Days to decision
65 days
Clearance type
Traditional
Product code
JOH
Device class
2
Regulation number
868.5800
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
St Louis, MO, US
Third-party review
No
Expedited review
No

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RecordFirmDate
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Recalls involving this device

RecordFirmDate
Shiley PED3.0 Cuffless Pediatric Tracheostomy Tube, REF 3.0 PED, Sterile. Tyco Healthcare recall (Z-0997-2009)Covidien Limited2009-03-04