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)

Inno-Hydrowire

K-Number: K172187 · 2018-04-11

ApplicantSuzhou Innomed Medical Device Co., Ltd.
Decision Date2018-04-11
Product CodeDQX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Inno-Hydrowire is the device name listed in this FDA 510(k) record. The listed applicant is Suzhou Innomed Medical Device Co., Ltd.. It received FDA 510(k) clearance on 2018-04-11 under 510(k) number K172187. 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 Inno-Hydrowire?

Inno-Hydrowire is a medical device that received FDA 510(k) clearance on 2018-04-11. The listed applicant is Suzhou Innomed Medical Device Co., Ltd.. The 510(k) number is K172187.

When did Inno-Hydrowire receive FDA 510(k) clearance?

Inno-Hydrowire received FDA 510(k) clearance on 2018-04-11, under 510(k) number K172187.

Who is the listed applicant for Inno-Hydrowire?

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

What is the FDA product code for Inno-Hydrowire?

The FDA product code for Inno-Hydrowire is DQX.

Other records listing Suzhou Innomed Medical Device 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.

K182553Inno-Pathwire

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.

↑