FDA 510(k)

ASAHI Caravel

K-Number: K152447 · 2016-01-22

Decision Date2016-01-22

Product CodeDQY

Advisory CommitteeCV

DecisionSubstantially Equivalent

Device Summary

ASAHI Caravel is a medical device manufactured by Asahi Intecc Co., Ltd.. It received FDA 510(k) clearance on 2016-01-22 under approval number K152447. 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 ASAHI Caravel?

ASAHI Caravel is a medical device that received FDA 510(k) clearance on 2016-01-22. It is manufactured by Asahi Intecc Co., Ltd.. The 510(k) number is K152447.

When was ASAHI Caravel approved by the FDA?

ASAHI Caravel received FDA 510(k) clearance on 2016-01-22, under approval number K152447.

What company makes ASAHI Caravel?

ASAHI Caravel is manufactured by Asahi Intecc Co., Ltd..

What is the FDA product code for ASAHI Caravel?

The FDA product code for ASAHI Caravel is DQY.

Other Devices by Asahi Intecc Co., Ltd.

K161912ASAHI Neurovascular Guide Wire: ASAHI CHIKAI black 14 soft tip K161584ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16 K161126ASAHI Corsair Pro K153106ASAHI Fielder XT-A, ASAHI Fielder XT-R K161362ASAHI Corsair Armet K160659ASAHI CHIKAI Neurovascular Guide Wire (Round Curve)

View all 45 devices →

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.) K162359Surefire Guiding CatheterSurefire 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.