Bard Tiger Guidewire Model 000540
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K962178 FDA 510(k)
- FDA Product Code
- OCY FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 876.1500 FDA 510(k)
- Regulation Number
- 876.1500 FDA 510(k)
- Advisory Committee
- Gastroenterology, Urology FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Bard Tiger Guidewire Model 000540 is an endoscopic guidewire designed to guide and exchange endoscopic accessories within the gastrointestinal tract. It is intended for use with devices that feature a .035 inch guidewire compatible lumen, facilitating access to the common bile, cystic, hepatic, and pancreatic ducts.
This device is a Class 2 medical device regulated under the gastroenterology and urology specialty. It received FDA 510(k) clearance through the traditional pathway.
Frequently asked questions
What is the primary purpose of the Bard Tiger Guidewire Model 000540?
This device is designed to guide and exchange endoscopic accessories within the gastrointestinal tract. It is specifically intended to facilitate access to the common bile, cystic, hepatic, and pancreatic ducts.
What equipment is compatible with this guidewire?
The Bard Tiger Guidewire Model 000540 is intended for use with endoscopic devices that feature a .035 inch guidewire compatible lumen.
What is the regulatory status of this device?
The Bard Tiger Guidewire Model 000540 is a Class 2 medical device that received FDA 510(k) clearance through the traditional pathway under the gastroenterology and urology specialty.
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: K962178 FDA 510 (k) - BARD TIGER GUIDEWIRE MODEL 000540, BARD TIGER GUIDEWIRE MODEL 000540 (K962178) — FDA 510(k) | Innolitics, PDF K962178 - Bard Tiger Guidewire Model 000540, C.R. Bard, Inc. · page 4 · DeviceClearance
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K962178 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K962178 24 fields · synced Sep 22, 2026