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Bard Lubricious Coated Ureteral Stent Suture

FDA 510(k)

Class II (US FDA 510(k))

510(k) K903345

by C. R. Bard, Inc.

Identifiers

510(k) Number
K903345 FDA 510(k)
FDA Product Code
FAD FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.4620 FDA 510(k)
Regulation Number
876.4620 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Bard Lubricious Coated Ureteral Stent Suture is a ureteral stent, a tube-like implanted device that provides ureteral rigidity and allows the passage of urine. It is a type of Stent, Ureteral, classified under the regulation number 876.4620.

The device is supplied with a lubricious coating and suture, and is intended for use in the ureter to relieve obstruction. It has been cleared under FDA 510(k) with the clearance type being Traditional, and has the product code FAD. The device is classified as a Class 2 device, with the medical specialty description being Gastroenterology, Urology.

Frequently asked questions

What is the Bard Lubricious-Coated Ureteral Stent Suture used for?

The Bard Lubricious-Coated Ureteral Stent Suture is a tube-like device intended to provide ureteral rigidity and facilitate urine flow. It is specifically designed to relieve obstruction in the ureter, helping maintain patency during urological procedures. The lubricious coating reduces friction, making placement and retention easier while ensuring stability within the ureter.

How is the Bard Lubricious-Coated Ureteral Stent Suture supplied?

This device is supplied pre-coated with a lubricious material and includes a suture for secure placement. The coating helps minimize irritation and friction during insertion and dwell time, while the suture aids in anchoring the stent in place. It is intended for single-use applications in clinical settings.

Is the Bard Lubricious-Coated Ureteral Stent Suture sterile?

While the provided data does not explicitly state sterility status, ureteral stents like this are typically supplied in sterile packaging to ensure safety for implantation. Sterility is a critical requirement for devices intended for internal use, so it is reasonable to assume this stent follows standard sterile manufacturing practices. Always verify packaging integrity before use.

Are there different sizes or models available for the Bard Lubricious-Coated Ureteral Stent Suture?

The data includes multiple registration numbers (e.g., 2527072, 3021632375) which likely correspond to different sizes or variations of the stent. These variations may account for differences in patient anatomy or clinical needs, such as varying ureteral diameters. For specific sizing details, refer to the manufacturer’s product catalog or technical documentation.

How should the Bard Lubricious-Coated Ureteral Stent Suture be stored?

As with most medical devices, the Bard Lubricious-Coated Ureteral Stent Suture should be stored in its original, unopened packaging to maintain sterility and integrity. It should be kept in a clean, dry environment away from direct sunlight, extreme temperatures, and sources of contamination. Always follow the manufacturer’s storage guidelines to ensure optimal performance and safety.

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: Bard (R) Lubricious - Coated Ureteral Stent Suture (K903345) — Fda 510 ..., Inlay™ Ureteral Stent - BD, K903345 FDA 510(k) - BARD LUBRICIOUS - COATED URETERAL STENT...

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) K903345 24 fields · synced Oct 1, 2026