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FDA 510(k)

NovaCross Microcatheter

K-Number: K160389 · 2016-03-11

ApplicantNitiloop , Ltd.
Decision Date2016-03-11
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NovaCross Microcatheter is the device name listed in this FDA 510(k) record. The listed applicant is Nitiloop , Ltd.. It received FDA 510(k) clearance on 2016-03-11 under 510(k) number K160389. 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 NovaCross Microcatheter?

NovaCross Microcatheter is a medical device that received FDA 510(k) clearance on 2016-03-11. The listed applicant is Nitiloop , Ltd.. The 510(k) number is K160389.

When did NovaCross Microcatheter receive FDA 510(k) clearance?

NovaCross Microcatheter received FDA 510(k) clearance on 2016-03-11, under 510(k) number K160389.

Who is the listed applicant for NovaCross Microcatheter?

The FDA 510(k) record lists Nitiloop , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NovaCross Microcatheter?

The FDA product code for NovaCross Microcatheter is DQY.

Other records listing Nitiloop , 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.

K193322NovaCross CTO MicrocatheterK172297NovaCross Microcatheter

Related Devices (Code: DQY)

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.

K260559NHanceITIMDS Operation B.V.K262392APRO 35 Swift CatheterAlembic, LLCK262240SSPC NXT Delivery CatheterCenterPoint Systems, LLCK261766CPS Locator 3D Plus Delivery CatheterCenterPoint Systems, LLCK261825Amplatzer TorqVue LP Delivery System; Amplatzer TorqVue LP CatheterAbbottK261631Amplatzer TorqVue Exchange SystemAbbott Medical

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.

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