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Hemostatic Y Connector

by Thomas Medical Products, Inc.

510(k) K911130

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 NumberK911130 Date6 Jun 1991ClearedStatusActive

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  • Withdrawn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, 1 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 Hemostatic Y Connector is a medical device classified as a Catheter, Angioplasty, Peripheral, Transluminal, designed to facilitate fluid transfer while maintaining hemostasis. It connects multiple lines or catheters in vascular procedures, ensuring secure sealing to prevent leakage or contamination during use. Its Y-shaped design allows for bifurcation of flow paths, enabling simultaneous infusion or drainage in peripheral angioplasty applications.

This device is supplied as a single-use, sterile component intended for use in controlled clinical environments such as catheterization labs or operating rooms. It is regulated under FDA 510(k) clearance (K911130) and falls under product code LIT, adhering to Class II special controls. No MRI safety or reusable specifications are indicated in the regulatory data. Storage conditions are not detailed but are typically maintained in a clean, dry environment until use.

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Questions

AI-generated answers, 1 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 Hemostatic Y Connector used for?

    The Hemostatic Y Connector is designed to facilitate fluid transfer while maintaining hemostasis in vascular procedures. Its Y-shaped design allows for the bifurcation of flow paths, enabling simultaneous infusion or drainage during peripheral angioplasty. This ensures secure sealing to prevent leakage or contamination, making it essential in controlled clinical environments like catheterization labs or operating rooms.

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

    The Hemostatic Y Connector is intended for single-use only. This design choice ensures patient safety by eliminating the risk of cross-contamination between uses. After a single procedure, the device should be discarded to comply with sterile medical device protocols.

  • What are the storage conditions for the Hemostatic Y Connector?

    While specific storage conditions are not detailed in the regulatory data, it is standard practice to maintain the Hemostatic Y Connector in a clean, dry environment until use. Avoid exposure to extreme temperatures, moisture, or direct sunlight to preserve sterility and functionality.

  • Does the Hemostatic Y Connector have any MRI safety considerations?

    The regulatory data does not indicate any MRI safety specifications for the Hemostatic Y Connector. If MRI compatibility is required for a procedure, additional verification or alternative devices should be considered to ensure patient safety.

  • What regulatory approval does the Hemostatic Y Connector hold?

    The Hemostatic Y Connector is regulated under FDA 510(k) clearance with the clearance number K911130. It falls under product code LIT and adheres to Class II special controls, ensuring it meets established safety and performance standards for its intended use in peripheral angioplasty procedures.