FDA 510(k)

Surefire Guiding Catheter

K-Number: K162359 · 2016-09-21

Decision Date2016-09-21

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

Surefire Guiding Catheter is a medical device manufactured by Surefire Medical, Inc.. It received FDA 510(k) clearance on 2016-09-21 under approval number K162359. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Surefire Guiding Catheter?

Surefire Guiding Catheter is a medical device that received FDA 510(k) clearance on 2016-09-21. It is manufactured by Surefire Medical, Inc.. The 510(k) number is K162359.

When was Surefire Guiding Catheter approved by the FDA?

Surefire Guiding Catheter received FDA 510(k) clearance on 2016-09-21, under approval number K162359.

What company makes Surefire Guiding Catheter?

Surefire Guiding Catheter is manufactured by Surefire Medical, Inc..

What is the FDA product code for Surefire Guiding Catheter?

The FDA product code for Surefire Guiding Catheter is DQY.

Related Clinical Trials

NCT07531368 BBAP With CS Mapping Guidance NOT_YET_RECRUITING

Other Devices by Surefire Medical, Inc.

K160662Surefire Infusion System K171355Surefire Precision Infusion System K180677Surefire Spark Infusion System

Related Devices (Code: DQY)

K163000AMPLATZER TorqVue 45x45 Delivery SheathAga Medical COrporation (Wholly Owned by St. Jude Medical CO K160561Boosting CatheterQxmedical, LLC K161546R2P SlenGuideAshitaka Factory of Terumo Corporation K161152Navien Intracranial Support CatheterMicro Therapeutics, Inc. d/b/a ev3 Neurovascular K162384TrailBlazer Angled Support CatheterMedtronic Vascular, Inc.(Formerly Ev3 Inc.) K161262Super Distal Access (SDA)Inneuroco, Inc.

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.