Pinpoint GT Introducer Needle
510(k) K162769
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK162769 | Date4 Nov 2016 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DYB
- FDA applicant
- C.R. Bard, Inc.
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1340
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Pinpoint GT Introducer Needle is a vascular access device classified under product code DYB, designed for percutaneous introduction of guidewires and subsequent catheter placement. It is a specialized needle intended to facilitate precise vascular access for embolization coil delivery or other interventional procedures requiring introducer access. Constructed for cardiovascular applications, it ensures accurate and controlled insertion into blood vessels.
This device is supplied as a single-use, sterile instrument and is intended for use in clinical settings such as catheterization labs or interventional radiology. It is regulated under FDA 510(k) clearance (K162769) and falls under the Cardiovascular advisory committee classification. No additional regulatory status or MRI safety information is specified in the provided data.
Other devices from C. R. Bard, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Pinpoint GT Introducer Needle used for?
The Pinpoint GT Introducer Needle is designed specifically for percutaneous introduction of guidewires and subsequent catheter placement in vascular access procedures. Its primary purpose is to facilitate precise and controlled insertion into blood vessels, making it ideal for embolization coil delivery or other interventional radiology applications requiring introducer access.
Is the Pinpoint GT Introducer Needle sterile and single-use?
Yes, the Pinpoint GT Introducer Needle is supplied as a sterile, single-use instrument. This ensures patient safety by preventing cross-contamination and reduces the risk of infection, aligning with clinical best practices for vascular access devices.
Where can the Pinpoint GT Introducer Needle be used?
This device is intended for use in controlled clinical settings such as catheterization labs or interventional radiology suites. Its design supports specialized cardiovascular procedures where accurate vascular access is critical.
What regulatory clearance does the Pinpoint GT Introducer Needle hold?
The Pinpoint GT Introducer Needle has received FDA 510(k) clearance under the classification of product code DYB, with a clearance number of K162769. It was reviewed by the Cardiovascular Advisory Committee and classified as substantially equivalent to predicate devices.
Are there different sizes or models available for the Pinpoint GT Introducer Needle?
The provided data does not specify multiple sizes or models for the Pinpoint GT Introducer Needle. However, its design is tailored for precise vascular access, which may accommodate various procedural needs within its intended use. For exact specifications, consult the manufacturer’s product documentation.