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FDA 510(k)

HOPER PTCA BALLOON CATHETER

K-Number: K123473 · 2013-08-13

ApplicantLepu Medical Technology (Beijing) Co., Ltd.
Decision Date2013-08-13
Product CodeLOX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HOPER PTCA BALLOON CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Lepu Medical Technology (Beijing) Co., Ltd.. It received FDA 510(k) clearance on 2013-08-13 under 510(k) number K123473. The device is classified under product code LOX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HOPER PTCA BALLOON CATHETER?

HOPER PTCA BALLOON CATHETER is a medical device that received FDA 510(k) clearance on 2013-08-13. The listed applicant is Lepu Medical Technology (Beijing) Co., Ltd.. The 510(k) number is K123473.

When did HOPER PTCA BALLOON CATHETER receive FDA 510(k) clearance?

HOPER PTCA BALLOON CATHETER received FDA 510(k) clearance on 2013-08-13, under 510(k) number K123473.

Who is the listed applicant for HOPER PTCA BALLOON CATHETER?

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

What is the FDA product code for HOPER PTCA BALLOON CATHETER?

The FDA product code for HOPER PTCA BALLOON CATHETER is LOX.

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Other records listing Lepu Medical Technology (Beijing) Co., Ltd. as applicant

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Related Devices (Code: LOX)

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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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