Sunmed Haemostatic Valves
K-Number: K153685 · 2016-10-13
Decision Date2016-10-13
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Sunmed Haemostatic Valves is a medical device manufactured by Sunny Medical Device (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2016-10-13 under approval number K153685. The device is classified under product code DQX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Sunmed Haemostatic Valves?
Sunmed Haemostatic Valves is a medical device that received FDA 510(k) clearance on 2016-10-13. It is manufactured by Sunny Medical Device (Shenzhen) Co., Ltd.. The 510(k) number is K153685.
When was Sunmed Haemostatic Valves approved by the FDA?
Sunmed Haemostatic Valves received FDA 510(k) clearance on 2016-10-13, under approval number K153685.
What company makes Sunmed Haemostatic Valves?
Sunmed Haemostatic Valves is manufactured by Sunny Medical Device (Shenzhen) Co., Ltd..
What is the FDA product code for Sunmed Haemostatic Valves?
The FDA product code for Sunmed Haemostatic Valves is DQX.
Other Devices by Sunny Medical Device (Shenzhen) Co., Ltd.
Related Devices (Code: DQX)
K160785Worker GuidewireArgon Medical Devices, Inc.
K161702Endura guidewireVascular Solutions, Inc.
K160594MRWire Guide WireNano4imaging GmbH
K160643ENROUTE 0.014 GuidewireLake Region Medical
K161584ASAHI® Peripheral Vascular Guide Wire ASAHI Meister®16Asahi Intecc Co., Ltd.
K161887Verrata PLUS Pressure Guide Wire, 185 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 185 cm J-Tip, Verrata PLUS Pressure Guide Wire, 300 cm Straight Tip, Verrata PLUS Pressure Guide Wire, 300 cm J-TipVolcano 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.