Atlas FDA

SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA

FDA 510(k) clearance K003315 · decided 2000-11-08

Clearance details

K-number
K003315
Device name
SHILEY TRACHEOSOFT XLT EXTENDED LENGTH TRACHEOSTOMY TUBE AND DISPOSABLE INNER CANNULA
Applicant
Mallinckrodt, Inc.
Decision
Substantially Equivalent
Date received
2000-10-23
Decision date
2000-11-08
Days to decision
16 days
Clearance type
Special
Product code
JOH
Device class
2
Regulation number
868.5800
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
St. Charles, MO, US
Third-party review
No
Expedited review
No

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Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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Recalls involving this device

RecordFirmDate
Shiley TracheoSoft XLT Extended Length Tracheostomy tube; Model Numbers: 72110-050, size 5 recall (Z-1312-04)Nellcor Puritan Bennett2004-08-07