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FDA 510(k)

TK Intravascular Administration Set

K-Number: K191640 · 2020-08-26

ApplicantAnhui Tiankang Medical Technology Co., Ltd.
Decision Date2020-08-26
Product CodeFPA
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

TK Intravascular Administration Set is the device name listed in this FDA 510(k) record. The listed applicant is Anhui Tiankang Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2020-08-26 under 510(k) number K191640. The device is classified under product code FPA. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TK Intravascular Administration Set?

TK Intravascular Administration Set is a medical device that received FDA 510(k) clearance on 2020-08-26. The listed applicant is Anhui Tiankang Medical Technology Co., Ltd.. The 510(k) number is K191640.

When did TK Intravascular Administration Set receive FDA 510(k) clearance?

TK Intravascular Administration Set received FDA 510(k) clearance on 2020-08-26, under 510(k) number K191640.

Who is the listed applicant for TK Intravascular Administration Set?

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

What is the FDA product code for TK Intravascular Administration Set?

The FDA product code for TK Intravascular Administration Set is FPA.

Other records listing Anhui Tiankang Medical Technology Co., Ltd. as applicant

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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.

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