PW Guidewires
510(k) K152497
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK152497 | Date22 Jan 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- Withdrawn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
- DQX
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.1330
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The PW Guidewires are Steerable Guidewires (DQX), designed to assist in the placement of balloon dilatation catheters or other intravascular devices within coronary and peripheral vasculature. These devices feature a flexible, steerable tip to navigate complex vascular anatomy, excluding use in cerebral blood vessels. Constructed from stainless steel, they are engineered for precision and durability in interventional procedures.
Supplied as single-use devices, PW Guidewires are intended for use in clinical settings such as cardiac catheterization labs and peripheral vascular interventions. Each guidewire measures a maximum diameter of 0.014 inches (0.36 mm) and has a nominal length of 180 cm, with regulatory clearance under FDA 510(k) K152497 via the Traditional pathway. Sterility and packaging details are not specified but must comply with FDA requirements for Class II cardiovascular devices. Storage conditions are manufacturer-defined but typically involve protection from moisture and physical damage.
Questions
AI-generated answers, 1 Oct 2026
What are PW Guidewires designed to assist with in vascular procedures?
PW Guidewires are engineered as steerable guidewires (DQX category) to facilitate the placement of balloon dilatation catheters or other intravascular devices. Their flexible, steerable tip enables precise navigation through complex coronary and peripheral blood vessels, improving procedural success in interventional settings like cardiac catheterization labs and peripheral vascular interventions.
Are PW Guidewires reusable or intended for single-use?
PW Guidewires are explicitly supplied as single-use devices. This design choice aligns with FDA requirements for Class II cardiovascular devices, ensuring sterility and reducing cross-contamination risks in clinical settings. Single-use also eliminates the need for reprocessing, streamlining workflow in interventional procedures.
What are the key dimensions of the PW Guidewires?
Each PW Guidewire has a nominal length of 180 centimeters and a maximum diameter of 0.014 inches (0.36 mm). These specifications are optimized for compatibility with standard coronary and peripheral vascular access techniques, allowing clinicians to select the appropriate length for their procedural needs while maintaining flexibility and steerability.
How should PW Guidewires be stored according to manufacturer guidelines?
While specific storage conditions are not detailed in the device data, PW Guidewires must be protected from moisture and physical damage to maintain integrity. Standard practices for Class II medical devices recommend storing them in their original packaging in a clean, dry environment away from direct sunlight or extreme temperatures until use.
What regulatory pathway was used for FDA clearance of PW Guidewires?
PW Guidewires received FDA clearance under the Traditional 510(k) pathway (K152497) with a decision code of SESE (Substantially Equivalent). This classification confirms the device meets performance criteria for existing legally marketed guidewires in the cardiovascular category, ensuring compliance with FDA standards for interventional vascular tools.