Atlas FDA

HEARTSTRING III PROXIMAL SEAL SYSTEM

FDA 510(k) clearance K130382 · decided 2013-06-05

Clearance details

K-number
K130382
Device name
HEARTSTRING III PROXIMAL SEAL SYSTEM
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2013-02-14
Decision date
2013-06-05
Days to decision
111 days
Clearance type
Traditional
Product code
DXC
Device class
2
Regulation number
870.4450
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Wayne, NJ, US
Third-party review
No
Expedited review
No

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