Pinpoint GT Safety Introducer Needle
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K142445 FDA 510(k)
- FDA Product Code
- DYB FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1340 FDA 510(k)
- Regulation Number
- 870.1340 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pinpoint GT Safety Introducer Needle is a vascular access device classified under product code DYB, designed for introducing guidewires or catheters into the vascular system. It features safety mechanisms to reduce the risk of accidental needle sticks, enhancing procedural safety for both patients and healthcare providers. This device is intended for use in interventional radiology and cardiology procedures where precise vascular access is required. Its design prioritizes controlled insertion and withdrawal to minimize complications during catheterization or embolization procedures.
The Pinpoint GT Safety Introducer Needle is supplied as a single-use, sterile device and is intended for use in controlled clinical settings such as operating rooms or catheterization labs. It is cleared for use under FDA 510(k) authorization (K142445) and falls under the Cardiovascular advisory committee classification. The device is not MRI-compatible and must be handled according to standard aseptic techniques. Storage instructions and additional regulatory details are specified in the accompanying packaging.
Frequently asked questions
What is the Pinpoint GT Safety Introducer Needle used for?
The Pinpoint GT Safety Introducer Needle is designed specifically for introducing guidewires or catheters into the vascular system during interventional radiology and cardiology procedures. Its primary purpose is to provide precise vascular access while minimizing complications such as accidental needle sticks, thanks to its built-in safety mechanisms. This makes it ideal for procedures like catheterization or embolization where controlled insertion and withdrawal are critical.
Is the Pinpoint GT Safety Introducer Needle single-use or reusable?
The Pinpoint GT Safety Introducer Needle is supplied as a single-use device. This design choice ensures sterility and reduces the risk of cross-contamination between patients, adhering to best practices for medical devices used in controlled clinical settings like operating rooms or catheterization labs. Single-use also eliminates the need for reprocessing, which can introduce additional risks.
How should the Pinpoint GT Safety Introducer Needle be stored?
The Pinpoint GT Safety Introducer Needle must be stored according to the instructions provided in its packaging. As a sterile device, it should be kept in a sealed, sterile barrier until use to maintain its integrity. Storage conditions should comply with standard aseptic techniques to prevent contamination. Avoid exposure to extreme temperatures or moisture, which could compromise the device’s performance or sterility.
Is the Pinpoint GT Safety Introducer Needle MRI-compatible?
No, the Pinpoint GT Safety Introducer Needle is explicitly stated as not MRI-compatible. This means it should not be used in or near MRI equipment, as the magnetic fields could potentially affect the device’s structure or function. Always verify device compatibility with imaging modalities before use to ensure patient safety and procedural accuracy.
What safety features does the Pinpoint GT Safety Introducer Needle include?
The Pinpoint GT Safety Introducer Needle incorporates safety mechanisms to reduce the risk of accidental needle sticks, a common hazard during vascular procedures. Its design prioritizes controlled insertion and withdrawal, which helps minimize complications such as vascular damage or unintended punctures. These features are particularly beneficial in high-stakes environments like interventional radiology and cardiology, where precision and safety are paramount.
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: Pinpoint GT Safety Introducer Needle - C.R. Bard | FDA Reference, Pinpoint GT Introducer Needle - C.R. Bard | FDA Reference, K142445 FDA 510 (k) - PINPOINT GT SAFETY INTRODUCER NEEDLE
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K142445 | Class II | Active |
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Manufacturer
- Manufacturer
- C. R. Bard, Inc.
- FDA Applicant
- C.R. Bard, Inc.
Sources (1)
- FDA 510(k) K142445 24 fields · synced Oct 1, 2026