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FDA 510(k)

Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath

K-Number: K232037 · 2024-04-04

ApplicantInnovative Health, LLC
Decision Date2024-04-04
Product CodePNE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath is a medical device manufactured by Innovative Health, LLC. It received FDA 510(k) clearance on 2024-04-04 under approval number K232037. The device is classified under product code PNE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath?

Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath is a medical device that received FDA 510(k) clearance on 2024-04-04. It is manufactured by Innovative Health, LLC. The 510(k) number is K232037.

When was Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath approved by the FDA?

Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath received FDA 510(k) clearance on 2024-04-04, under approval number K232037.

What company makes Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath?

Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath is manufactured by Innovative Health, LLC.

What is the FDA product code for Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath?

The FDA product code for Reprocessed VersaCross Steerable Sheath; Reprocessed SureFlex Steerable Guiding Sheath is PNE.

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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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