Atlas FDA

PORTEX PERCUTANEOUS TRACHEOSTOMY KIT

FDA 510(k) clearance K060945 · decided 2006-06-19

Clearance details

K-number
K060945
Device name
PORTEX PERCUTANEOUS TRACHEOSTOMY KIT
Applicant
Smiths Medical International
Decision
Substantially Equivalent
Date received
2006-04-06
Decision date
2006-06-19
Days to decision
74 days
Clearance type
Traditional
Product code
BTO
Device class
2
Regulation number
868.5800
Medical specialty
Anesthesiology
Advisory committee
Anesthesiology
Location
Rossendale, Lancashire, GB
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.