FDA 510(k)

HeartLight Deflectable Sheath

K-Number: K152310 · 2016-02-24

Decision Date2016-02-24

Product CodeDRA

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

HeartLight Deflectable Sheath is a medical device manufactured by Cardiofocus, Inc.. It received FDA 510(k) clearance on 2016-02-24 under approval number K152310. 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 HeartLight Deflectable Sheath?

HeartLight Deflectable Sheath is a medical device that received FDA 510(k) clearance on 2016-02-24. It is manufactured by Cardiofocus, Inc.. The 510(k) number is K152310.

When was HeartLight Deflectable Sheath approved by the FDA?

HeartLight Deflectable Sheath received FDA 510(k) clearance on 2016-02-24, under approval number K152310.

What company makes HeartLight Deflectable Sheath?

HeartLight Deflectable Sheath is manufactured by Cardiofocus, Inc..

What is the FDA product code for HeartLight Deflectable Sheath?

The FDA product code for HeartLight Deflectable Sheath is DRA.

Other Devices by Cardiofocus, Inc.

PMA P150026Catheter, percutaneous, cardiac ablation, for treatment of atrial fibrillation

Related Devices (Code: DRA)

K160919Hansen Medical Magellan Robotic Catheter 9FrHansen Medical, Inc. K161985Steerable Guide CatheterAbbott Vascular K153304Hansen Medical Magellan Robotic Catheter eKitHansen Medical, Inc. K172394Steerable Guide CatheterAbbott Vascular K162925AcQGuide Steerable SheathAcutus Medical, Inc. K183174FlexCath Advance Steerable Sheath and DilatorMedtronic Cryocath, LP

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.