Atlas FDA

TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934

FDA 510(k) clearance K052413 · decided 2005-11-17

Clearance details

K-number
K052413
Device name
TUNA SYSTEM, MODELS 8909, 8929, 8930, 8934
Applicant
Medtronic Vascular
Decision
Substantially Equivalent
Date received
2005-09-02
Decision date
2005-11-17
Days to decision
76 days
Clearance type
Traditional
Product code
KNS
Device class
2
Regulation number
876.4300
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Shoreview, MN, US
Third-party review
Yes
Expedited review
No

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