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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 the device name listed in this FDA 510(k) record. The listed applicant is Medtronic, Inc.. It received FDA 510(k) clearance on 2023-10-31 under 510(k) 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. The listed applicant is Medtronic, Inc.. The 510(k) number is K232321.

When did FlexCath Contour™ Steerable Sheath receive FDA 510(k) clearance?

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

Who is the listed applicant for FlexCath Contour™ Steerable Sheath?

The FDA 510(k) record lists Medtronic, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: DRA)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262165FARADRIVE™ Steerable Sheath (M004PF21M402)Boston Scientific CorporationK250529Globe Introducer (601-01001)Kardium, Inc.K233248FARADRIVE™ Steerable SheathBoston Scientific CorporationK223824POLARSHEATH™ Steerable Sheath 12F (UPN:M004CRBS3150), POLARMAP™ Circular Mapping Catheter (UPN:M004CRBS7210), POLARMAP™ EP Electrical Cable (UPN:M004CRBS62000), SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable: -SMARTFREEZE™ Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6310), -SMARTFREEZE™ 16 PIN Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6320), -SMARTFREEZE™ CIRCA Esophageal Temperature Sensor (ETS) Cable (UPN: M004CRBS6340), SMARTFREEZE™ Pressure SensorBoston Scientific CorporationK221397MitraClip G4 Steerable Guide CatheterABBOTT MEDICALK221044AcQGuide® VUE 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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