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FDA 510(k)

Arcadia Balloon Catheter

K-Number: K191596 · 2019-10-09

ApplicantMerit Medical Systems, Inc.
Decision Date2019-10-09
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

Arcadia Balloon Catheter is a medical device manufactured by Merit Medical Systems, Inc.. It received FDA 510(k) clearance on 2019-10-09 under approval number K191596. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Arcadia Balloon Catheter?

Arcadia Balloon Catheter is a medical device that received FDA 510(k) clearance on 2019-10-09. It is manufactured by Merit Medical Systems, Inc.. The 510(k) number is K191596.

When was Arcadia Balloon Catheter approved by the FDA?

Arcadia Balloon Catheter received FDA 510(k) clearance on 2019-10-09, under approval number K191596.

What company makes Arcadia Balloon Catheter?

Arcadia Balloon Catheter is manufactured by Merit Medical Systems, Inc..

What is the FDA product code for Arcadia Balloon Catheter?

The FDA product code for Arcadia Balloon Catheter is HRX.

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Related Devices (Code: HRX)

K162062AVAmax Vertebral Balloon, AVAflex Vertebral BalloonStryker Corporation K161878PORTAGE SystemBaylis Medical Company, Inc. K162475mi-eye 2, mi-eye 2 monitorTrice Medical K152511Neo - Arthroscope (Rigid) 2.0mm/3.5mm, Outer sheath/ cannula, Outer sheath/ cannula w/ Handle, Trocar for outersheath/ cannulaProsurg, Inc. K160249ULTRA TelescopesOlympus Winter & Ibe GmbH K151932Stryker CrossFlow Day-Use Inflow Cassette Tubing and Patient-Use TubingStryker Corporation

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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