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Excel Y-Connector Cat. #E-201

by Medical Profiles, Inc.

510(k) K884327

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK884327 Date19 Apr 1989ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
LIT
Device Class
Class II
Regulation
21 CFR Part 870.1250
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Excel Y-Connector Cat. #E-201 is a catheter, angioplasty, peripheral, transluminal device. It is a Y-connector configuration with a touhy-borst style adapter and rotating male luer, designed to minimize fluid loss during interventional procedures.

The device is supplied with a product code of LIT and a regulation number of 870.1250. It has been cleared by the FDA with a 510(k) number of K884327. The device is intended for use in cardiovascular medical specialty procedures.

Other devices from Medical Profiles, Inc.

Questions

AI-generated answers, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Excel Y-Connector used for?

    The Excel Y-Connector is intended for use in cardiovascular medical specialty procedures, specifically for minimizing fluid loss during interventional procedures.

  • How is the Excel Y-Connector supplied?

    The device is supplied with a product code of LIT and a regulation number of 870.1250, and has been cleared by the FDA with a 510(k) number of K884327.

  • Is the Excel Y-Connector sterile?

    The device data does not explicitly state the sterility of the Excel Y-Connector, but it is designed for use in medical procedures and is subject to regulatory clearance.

  • Is the Excel Y-Connector single-use or reusable?

    The device data does not specify whether the Excel Y-Connector is single-use or reusable, but its design and materials suggest it may be intended for single-use.