Atlas FDA

WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL

FDA 510(k) clearance K152842 · decided 2016-05-19

Clearance details

K-number
K152842
Device name
WALLSTENT RP ENDOPROSTHESIS TRACHEOBRONCHIAL, WALLSTENT ENDOPROSTHESIS TRACHEOBRONCHIAL
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2015-09-29
Decision date
2016-05-19
Days to decision
233 days
Clearance type
Traditional
Product code
JCT
Device class
2
Regulation number
878.3720
Medical specialty
General, Plastic Surgery
Advisory committee
General, Plastic Surgery
Location
Maple Grove, MN, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

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