BARD Director Guidewire (000560)
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K964780 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 Director Guidewire is an endoscopic guidewire used to guide endoscopic accessories into the gastrointestinal tract and for cannulation procedures. It is compatible with devices having a .035" guidewire compatible lumen and is substantially equivalent to other marketed guidewires.
The device is manufactured by C.R. Bard, Inc. and received FDA 510(k) clearance with K number K964780 on February 26, 1997. It is classified under product code OCY and regulation number 876.1500. The device is intended for use in gastroenterology and urology procedures.
Frequently asked questions
What is the Bard Director Guidewire used for?
The Bard Director Guidewire is an endoscopic guidewire designed to guide endoscopic accessories into the gastrointestinal tract and for cannulation procedures. It is compatible with devices having a .035" guidewire compatible lumen.
Is the Bard Director Guidewire single-use or reusable?
The device data does not specify whether the Bard Director Guidewire is single-use or reusable. This information would typically be found in the device's instructions for use or product labeling.
What are the regulatory approvals for the Bard Director Guidewire?
The Bard Director Guidewire received FDA 510(k) clearance with K number K964780 on February 26, 1997. It is classified under product code OCY and regulation number 876.1500, intended for use in gastroenterology and urology procedures.
What devices is the Bard Director Guidewire compatible with?
The Bard Director Guidewire is compatible with devices having a .035" guidewire compatible lumen. It is substantially equivalent to other marketed guidewires with the same specifications.
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 DIRECTOR GUIDEWIRE (000560) by C.R. BARD, INC. | FDA 510 (k) Summary, K964780 FDA 510(k) - BARD DIRECTOR GUIDEWIRE (000560), BARD DIRECTOR GUIDEWIRE (000560) (K964780) — FDA 510 (k) | Innolitics, PDF K964780 - Bard Director Guidewire (000560)
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K964780 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K964780 24 fields · synced Sep 26, 2026