510(k) K233248

Device
FARADRIVE? Steerable Sheath
Applicant
Boston Scientific Corporation
510(k) number
K233248
Product code
DRA
Decision
Substantially Equivalent (SESE)
Decision date
2023-12-11
Date received
2023-09-28
Regulation
870.1280
Classification name
Catheter, Steerable
Medical specialty
Cardiovascular
Review panel
Cardiovascular
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Related Records

Applicant Contact

Contact
Nicholas Zurn
Address
4100 Hamline Ave. N St Paul MN US 55112 55112

FDA Registration Numbers

Source Documents

510(k) summary PDF

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