Atlas FDA

IN-TIME RETRIEVAL DEVICE

FDA 510(k) clearance K014109 · decided 2002-03-12

Clearance details

K-number
K014109
Device name
IN-TIME RETRIEVAL DEVICE
Applicant
Boston Scientific, Target
Decision
Substantially Equivalent
Date received
2001-12-14
Decision date
2002-03-12
Days to decision
88 days
Clearance type
Traditional
Product code
MMX
Device class
2
Regulation number
870.5150
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Fremont, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.