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FDA 510(k)

LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM

K-Number: K152876 · 2016-01-08

ApplicantTni Manufacturing, Inc.
Decision Date2016-01-08
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM is the device name listed in this FDA 510(k) record. The listed applicant is Tni Manufacturing, Inc.. It received FDA 510(k) clearance on 2016-01-08 under 510(k) number K152876. 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 LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM?

LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM is a medical device that received FDA 510(k) clearance on 2016-01-08. The listed applicant is Tni Manufacturing, Inc.. The 510(k) number is K152876.

When did LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM receive FDA 510(k) clearance?

LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM received FDA 510(k) clearance on 2016-01-08, under 510(k) number K152876.

Who is the listed applicant for LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM?

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

What is the FDA product code for LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM?

The FDA product code for LONG SHEATH OR LS, 70 CM, LONG SHEATH OR LS, 80 CM, LONG SHEATH OR LS, 90 CM is DQY.

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.

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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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