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FDA 510(k)

FlexCath Contour™ Steerable Sheath

K-Number: K232321 · 2023-10-31

ApplicantMedtronic, Inc.
Decision Date2023-10-31
Product CodeDRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FlexCath Contour™ Steerable Sheath is a medical device manufactured by Medtronic, Inc.. It received FDA 510(k) clearance on 2023-10-31 under approval number K232321. The device is classified under product code DRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FlexCath Contour™ Steerable Sheath?

FlexCath Contour™ Steerable Sheath is a medical device that received FDA 510(k) clearance on 2023-10-31. It is manufactured by Medtronic, Inc.. The 510(k) number is K232321.

When was FlexCath Contour™ Steerable Sheath approved by the FDA?

FlexCath Contour™ Steerable Sheath received FDA 510(k) clearance on 2023-10-31, under approval number K232321.

What company makes FlexCath Contour™ Steerable Sheath?

FlexCath Contour™ Steerable Sheath is manufactured by Medtronic, Inc..

What is the FDA product code for FlexCath Contour™ Steerable Sheath?

The FDA product code for FlexCath Contour™ Steerable Sheath is DRA.

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K160919Hansen Medical Magellan Robotic Catheter 9FrHansen Medical, Inc. K161985Steerable Guide CatheterAbbott Vascular K152310HeartLight Deflectable SheathCardiofocus, Inc. K153304Hansen Medical Magellan Robotic Catheter eKitHansen Medical, Inc. K172394Steerable Guide CatheterAbbott Vascular K162925AcQGuide Steerable SheathAcutus Medical, Inc.

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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