Atlas FDA

SIMON NITINOL FILTER, MODIFICATION

FDA 510(k) clearance K912144 · decided 1991-10-17

Clearance details

K-number
K912144
Device name
SIMON NITINOL FILTER, MODIFICATION
Applicant
Nitinol Medical Technologies, Inc.
Decision
Substantially Equivalent
Date received
1991-05-13
Decision date
1991-10-17
Days to decision
157 days
Clearance type
Traditional
Product code
DTK
Device class
2
Regulation number
870.3375
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
New York, NY, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.