Atlas FDA

RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX

FDA 510(k) clearance K100892 · decided 2010-04-12

Clearance details

K-number
K100892
Device name
RENEGADE HI-FLO FATHOM KIT MODEL M001182XXX
Applicant
Boston Scientific Corp
Decision
Substantially Equivalent
Date received
2010-03-31
Decision date
2010-04-12
Days to decision
12 days
Clearance type
Special
Product code
KRA
Device class
2
Regulation number
870.1210
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
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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