Atlas FDA

VersaCross Transseptal Sheath

FDA 510(k) clearance K183655 · decided 2019-05-20

Clearance details

K-number
K183655
Device name
VersaCross Transseptal Sheath
Applicant
Baylis Medical Company, Inc.
Decision
Substantially Equivalent
Date received
2018-12-27
Decision date
2019-05-20
Days to decision
144 days
Clearance type
Traditional
Product code
DYB
Device class
2
Regulation number
870.1340
Medical specialty
Cardiovascular
Advisory committee
Cardiovascular
Location
Mississauga, CA
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
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Echo Large Bore Introducer Sheath (K260606)Echo Medical, LLC2026-04-29
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Recalls involving this device

RecordFirmDate
VersaCross Access Solution (VXSK), Product Description and ID: VXSK (180J RF WIRE 63CM/45D recall (Z-2103-2025)Boston Scientific Corporation2025-07-10
VersaCross Transseptal Sheath Kit (VXS) Product Description/IDs VXS0201 VXS 63CM/45DEG/D0 recall (Z-2105-2025)Boston Scientific Corporation2025-07-10
Torflex Transseptal Guiding Sheath Kit (TFK-M) TF85-32-63-45 TORFLEX 8.5F 63CM 45DEG TF85- recall (Z-2106-2025)Boston Scientific Corporation2025-07-10