Atlas FDA

SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM

FDA 510(k) clearance K970099 · decided 1997-04-16

Clearance details

K-number
K970099
Device name
SIMON NITINOL FILTER/STRAIGHT LINE SYSTEM
Applicant
Nitinol Medical Technologies, Inc.
Decision
Substantially Equivalent
Date received
1997-01-13
Decision date
1997-04-16
Days to decision
93 days
Clearance type
Traditional
Product code
DTK
Device class
2
Regulation number
870.3375
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Boston, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.