Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Sunmed Haemostatic Valves

K-Number: K153685 · 2016-10-13

ApplicantSunny Medical Device (Shenzhen) Co., Ltd.
Decision Date2016-10-13
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Sunmed Haemostatic Valves is the device name listed in this FDA 510(k) record. The listed applicant is Sunny Medical Device (Shenzhen) Co., Ltd.. It received FDA 510(k) clearance on 2016-10-13 under 510(k) 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. The listed applicant is Sunny Medical Device (Shenzhen) Co., Ltd.. The 510(k) number is K153685.

When did Sunmed Haemostatic Valves receive FDA 510(k) clearance?

Sunmed Haemostatic Valves received FDA 510(k) clearance on 2016-10-13, under 510(k) number K153685.

Who is the listed applicant for Sunmed Haemostatic Valves?

The FDA 510(k) record lists Sunny Medical Device (Shenzhen) Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Sunmed Haemostatic Valves?

The FDA product code for Sunmed Haemostatic Valves is DQX.

Other records listing Sunny Medical Device (Shenzhen) Co., Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K191827Sunmed Disposable Angio-Closure PadsK160190Sunmed Control Syringes

Related Devices (Code: DQX)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K253667Accoat Guide WireSp Medical A/SK261640Merit MAK Nitinol/Gold-Tungsten Guide WireMerit Medical Ireland , Ltd.K254137InQwire Amplatz Guide WireMerit Medical Ireland, Ltd.K260544FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40FMD Co., Ltd.K253746Enroute 0.014'' Transcarotid GuidewireLake Region MedicalK253262EmeryGlide™ (EG18008901)Nano4imaging GmbH

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.

↑