Indigo Lightning Flash Aspiration System Select + Catheter

The Indigo Lightning Flash Aspiration System Select + Catheter is specifically designed for use in interventional radiology or cardiology settings. This matters because these specialties have the expertise and infrastructure to safely perform mechanical thrombectomy procedures, ensuring proper handling of the device for clot removal in peripheral vasculature or pulmonary arteries. The system’s aspiration-based approach aligns with the precision and sterile environments required in these fields.

The device is supplied as a single-use system, meaning it is not meant to be reused after one procedure. This design choice reduces infection risks and ensures consistent performance, as reuse could compromise sterility or functionality. Clinicians must follow sterile preparation protocols before use, as outlined in the manufacturer’s instructions, to maintain safety and compliance with interventional standards.

The Select + Catheter is available in multiple reference codes (listed under `openfda: fei_number` in the data), which correspond to different sizes or configurations. These variations allow for tailored selection based on the vascular anatomy or clot characteristics of the patient. The manufacturer’s documentation or a product catalog should specify which codes align with common clinical scenarios (e.g., peripheral vs. pulmonary use). Always verify compatibility with your procedural goals before ordering.

The system is non-sterile as supplied, so it requires aseptic preparation prior to use, adhering to standard interventional catheter protocols. Storage should follow typical guidelines for medical devices: keep in a clean, dry environment, protected from contamination or physical damage. Avoid exposure to extreme temperatures or moisture. The manufacturer’s instructions will detail any additional handling requirements, such as packaging integrity checks or shelf-life considerations, to maintain device efficacy.

Classifying the device as Class II under FDA code 870.5150 (Peripheral Mechanical Thrombectomy With Aspiration) means it undergoes special controls to ensure safety and effectiveness, including performance standards and post-market surveillance. The device was granted FDA 510(k) clearance (K241399) as substantially equivalent to predicate devices, indicating it meets regulatory benchmarks for mechanical thrombectomy systems. This classification does not alter clinical use but confirms the device has undergone rigorous review for its intended purpose in revascularization procedures.