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FDA 510(k)

SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath

K-Number: K231227 · 2023-12-20

ApplicantBaylis Medical Company, Inc.
Decision Date2023-12-20
Product CodeDYB
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath is a medical device manufactured by Baylis Medical Company, Inc.. It received FDA 510(k) clearance on 2023-12-20 under approval number K231227. The device is classified under product code DYB. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath?

SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath is a medical device that received FDA 510(k) clearance on 2023-12-20. It is manufactured by Baylis Medical Company, Inc.. The 510(k) number is K231227.

When was SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath approved by the FDA?

SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath received FDA 510(k) clearance on 2023-12-20, under approval number K231227.

What company makes SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath?

SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath is manufactured by Baylis Medical Company, Inc..

What is the FDA product code for SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath?

The FDA product code for SureFlex HD Steerable Sheath, VersaCross HD Steerable Sheath is DYB.

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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