Atlas FDA

STAINLESS STEEL GREEN VENA CAVA FILT W/12F INTR SY

FDA 510(k) clearance K912035 · decided 1995-06-15

Clearance details

K-number
K912035
Device name
STAINLESS STEEL GREEN VENA CAVA FILT W/12F INTR SY
Applicant
Boston Scientific Corp
Decision
Substantially Equivalent
Date received
1991-05-09
Decision date
1995-06-15
Days to decision
1498 days
Clearance type
Traditional
Product code
DTK
Device class
2
Regulation number
870.3375
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Watertown, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

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