FDA 510(k)

Signal Catheter

K-Number: K182635 · 2019-01-10

Decision Date2019-01-10

Product CodeEZL

Advisory CommitteeGU

DecisionSubstantially Equivalent

Device Summary

Signal Catheter is a medical device manufactured by Safe Medical Design. It received FDA 510(k) clearance on 2019-01-10 under approval number K182635. The device is classified under product code EZL. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Signal Catheter?

Signal Catheter is a medical device that received FDA 510(k) clearance on 2019-01-10. It is manufactured by Safe Medical Design. The 510(k) number is K182635.

When was Signal Catheter approved by the FDA?

Signal Catheter received FDA 510(k) clearance on 2019-01-10, under approval number K182635.

What company makes Signal Catheter?

Signal Catheter is manufactured by Safe Medical Design.

What is the FDA product code for Signal Catheter?

The FDA product code for Signal Catheter is EZL.

Related Clinical Trials

NCT07610018 Cerebral Microembolization During Pulmonary Vein Isolation: Comparison of Different Pulsed Field Ablation Systems NOT_YET_RECRUITING NCT03053141 RHythmia mAPping and Signal acquisitiOn for Data analYsis (RHAPSODY) RECRUITING NCT05427929 Measuring Diaphragm Electrical Activity in Neonates Using a Smaller Inter-electrode Distance ACTIVE_NOT_RECRUITING

Related Devices (Code: EZL)

K153655Accuryn Monitoring SystemPotrero Medical, Inc. K161770Rusch Silicone Foley CatheterTeleflexmedical, Inc. K162989Rusch Simplastic Foley CathetersTeleflexmedical, Inc. K181616PSM 3-Way Silicone Foley CatheterPathway, LLC K180781Bard Vertus Foley CatheterC.R. Bard, Inc. K181814AMSure Pre-filled Syringe for Balloon Inflation with Sterile WaterAmsino International, 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.