Sidekick and Usher Support Catheters
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K131493 FDA 510(k)
- FDA Product Code
- DQY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1250 FDA 510(k)
- Regulation Number
- 870.1250 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Sidekick and Usher Support Catheters are single lumen catheters intended to create a pathway for other devices in the peripheral vasculature. They are flexible, tubular devices designed to provide support and guidance during the placement of vascular stents, helping navigate through the venous system to ensure accurate delivery and positioning of stents.
These catheters are supplied by C. R. Bard, Inc. and were cleared via the FDA 510(k) pathway under K131493 with product code DQY. They are classified as Class 2 Cardiovascular devices and were determined to be substantially equivalent through a traditional 510(k) review.
Frequently asked questions
What is the intended use of the Sidekick and Usher Support Catheters?
The Sidekick and Usher Support Catheters are intended to create a pathway for other devices in the peripheral vasculature, providing support and guidance during the placement of vascular stents to help navigate the venous system for accurate stent delivery and positioning.
How are the Sidekick and Usher Support Catheters supplied and are they reusable?
These catheters are supplied as single lumen, flexible tubular devices by C. R. Bard, Inc. and are intended for single-use only, as indicated by their classification as single lumen catheters designed to create a pathway for other devices without mention of reuse or reprocessing.
What regulatory pathway was used for the Sidekick and Usher Support Catheters and what is their classification?
The Sidekick and Usher Support Catheters were cleared via the FDA 510(k) pathway under submission K131493 with product code DQY and are classified as Class 2 Cardiovascular devices, determined to be substantially equivalent through a traditional 510(k) review.
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: K131493 FDA 510 (k) - SIDEKICK AND USHER SUPPORT CATHETERS, SIDEKICK AND USHER SUPPORT CATHETERS - Innolitics, Sidekick and Usher Support Catheters - Bard Peripheral Vascular | FDA ..., Sidekick and Usher Support Catheters - C.R. Bard | FDA Reference
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K131493 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K131493 24 fields · synced Sep 28, 2026