Atlas FDA

Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath

FDA 510(k) clearance K172929 · decided 2018-01-10

Clearance details

K-number
K172929
Device name
Amplatz Type Renal Sheaths, Amplatz Type Renal Sheath Set, and Clear Renal Sheath
Applicant
Boston Scientific Corporation
Decision
Substantially Equivalent
Date received
2017-09-25
Decision date
2018-01-10
Days to decision
107 days
Clearance type
Traditional
Product code
LJE
Device class
U
Medical specialty
Unknown
Advisory committee
Unknown
Location
Marlboro, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

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