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Usci Hemaquet Xt Introducer

FDA 510(k)

Class II (US FDA 510(k))

510(k) K920251

by C. R. Bard, Inc.

Identifiers

510(k) Number
K920251 FDA 510(k)
FDA Product Code
DYB FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1340 FDA 510(k)
Regulation Number
870.1340 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The USCI HEMAQUET XT INTRODUCER is a specialized catheter designed to aid in the placement of embolization coils within blood vessels. It is classified as a Class 2 cardiovascular device under product code DYB.

The device was cleared through the FDA 510(k) pathway on March 18, 1992, under traditional review with K-number K920251. It is manufactured by C.R. Bard, Inc. and is supplied as a single-use device for use in cardiovascular procedures.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: usci hemaquet xt introducer - C.R. Bard | FDA Reference, USCI HEMAQUET XT INTRODUCER (K920251) — FDA 510(k) | Innolitics, K920251 FDA 510 (k) - USCI HEMAQUET XT INTRODUCER, USCI HEMAQUET XT INTRODUCER (K920251) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
C. R. Bard, Inc.
FDA Applicant
C.R. Bard, Inc.

Sources (1)

  • FDA 510(k) K920251 24 fields · synced Sep 25, 2026