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FDA 510(k)

FlexCath Advance Steerable Sheath and Dilator

K-Number: K183174 · 2018-11-26

ApplicantMedtronic Cryocath, LP
Decision Date2018-11-26
Product CodeDRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FlexCath Advance Steerable Sheath and Dilator is the device name listed in this FDA 510(k) record. The listed applicant is Medtronic Cryocath, LP. It received FDA 510(k) clearance on 2018-11-26 under 510(k) number K183174. 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 Advance Steerable Sheath and Dilator?

FlexCath Advance Steerable Sheath and Dilator is a medical device that received FDA 510(k) clearance on 2018-11-26. The listed applicant is Medtronic Cryocath, LP. The 510(k) number is K183174.

When did FlexCath Advance Steerable Sheath and Dilator receive FDA 510(k) clearance?

FlexCath Advance Steerable Sheath and Dilator received FDA 510(k) clearance on 2018-11-26, under 510(k) number K183174.

Who is the listed applicant for FlexCath Advance Steerable Sheath and Dilator?

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

What is the FDA product code for FlexCath Advance Steerable Sheath and Dilator?

The FDA product code for FlexCath Advance Steerable Sheath and Dilator is DRA.

Other records listing Medtronic Cryocath, LP as applicant

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.

PMA P100010Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillationPMA P020045Cardiac ablation percutaneous catheterK202620FlexCath Advance Steerable Sheath and DilatorK163268FlexCath Select Steerable Shealth and Dilator

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 CorporationK232321FlexCath Contour™ Steerable SheathMedtronic, Inc.K223824POLARSHEATH™ 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 MEDICAL

Official Source

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

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