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FDA 510(k)

FlexCath Advance Steerable Sheath and Dilator

K-Number: K202620 · 2020-11-13

ApplicantMedtronic Cryocath, LP
Decision Date2020-11-13
Product CodeDRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FlexCath Advance Steerable Sheath and Dilator is a medical device manufactured by Medtronic Cryocath, LP. It received FDA 510(k) clearance on 2020-11-13 under approval number K202620. 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 2020-11-13. It is manufactured by Medtronic Cryocath, LP. The 510(k) number is K202620.

When was FlexCath Advance Steerable Sheath and Dilator approved by the FDA?

FlexCath Advance Steerable Sheath and Dilator received FDA 510(k) clearance on 2020-11-13, under approval number K202620.

What company makes FlexCath Advance Steerable Sheath and Dilator?

FlexCath Advance Steerable Sheath and Dilator is manufactured by Medtronic Cryocath, LP.

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 Devices by Medtronic Cryocath, LP

K163268FlexCath Select Steerable Shealth and Dilator K183174FlexCath Advance Steerable Sheath and Dilator PMA P020045Cardiac ablation percutaneous catheter PMA P100010Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Related Devices (Code: DRA)

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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