Atlas FDA

SIMON NITINOL FILTER

FDA 510(k) clearance K894703 · decided 1990-04-20

Clearance details

K-number
K894703
Device name
SIMON NITINOL FILTER
Applicant
Nitinol Medical Technologies, Inc.
Decision
Substantially Equivalent
Date received
1989-07-24
Decision date
1990-04-20
Days to decision
270 days
Clearance type
Traditional
Product code
DTK
Device class
2
Regulation number
870.3375
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Los Angles, CA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.