Atlas FDA

Glidesheath Slender

FDA 510(k) clearance K173831 · decided 2018-05-08

Clearance details

K-number
K173831
Device name
Glidesheath Slender
Applicant
Terumo Medical Corporation
Decision
Substantially Equivalent
Date received
2017-12-18
Decision date
2018-05-08
Days to decision
141 days
Clearance type
Traditional
Product code
DYB
Device class
2
Regulation number
870.1340
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Elkton, MD, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
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PMA approvals by this applicant

RecordFirmDate
MISAGO® RX Self-expanding Peripheral Stent (P140002/S031)Terumo Medical Corporation2025-12-12
MISAGO® RX Self-expanding Peripheral Stent (P140002/S030)Terumo Medical Corporation2025-09-12
Angio-Seal Vascular Closure Device (P930038/S106)Terumo Medical Corporation2025-08-07
MISAGO® RX Self-expanding Peripheral Stent; R2P Misago RX Self-expanding Peripheral Stent System (P140002/S029)Terumo Medical Corporation2025-08-05
ANGIO-SEAL VIP Vascular Closure Device (P930038/S105)Terumo Medical Corporation2024-11-26
MISAGO RX Self-expanding Peripheral Stent System, R2P MISAGO RX Self-expanding Peripheral Stent System (P140002/S028)Terumo Medical Corporation2024-11-14
Angio-Seal Vascular Closure Device (P930038/S103)Terumo Medical Corporation2024-11-08
Angio-Seal VIP Vascular Closure Devices (P930038/S102)Terumo Medical Corporation2024-08-23