Identifiers
- 510(k) Number
- K191731 FDA 510(k)
- FDA Product Code
- KRA FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 870.1210 FDA 510(k)
- Regulation Number
- 870.1210 FDA 510(k)
- Advisory Committee
- Cardiovascular FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Instylla Microcatheter is a continuous flush catheter designed for super selective vascular access in peripheral diagnostic and interventional procedures. It facilitates the precise delivery of diagnostic, embolic, or therapeutic agents into small vessels or complex anatomical regions, supporting targeted interventions such as angiography or embolization.
This device is supplied as a single-use, non-sterile catheter intended for sterile preparation prior to use. It is classified as a Class II medical device under FDA regulation 870.1210 and has received FDA 510(k) clearance (K191731) as substantially equivalent to predicate devices. Multiple reference codes (e.g., 3012543881, 1018233) identify compatible configurations, including varying lengths and diameters for specific procedural needs.
Frequently asked questions
What types of procedures is the Instylla Microcatheter designed to support, and why is precise delivery important in these cases?
The Instylla Microcatheter is specifically designed for super selective vascular access in peripheral diagnostic and interventional procedures, such as angiography or embolization. Precise delivery of diagnostic, embolic, or therapeutic agents into small vessels or complex anatomical regions is critical because these interventions often require targeting specific areas—like arteriovenous malformations, tumors, or narrow blood vessels—to minimize damage to surrounding healthy tissue and ensure the treatment is effective.
Is the Instylla Microcatheter sterile when received, and what preparation is required before use?
The Instylla Microcatheter is supplied as non-sterile and must be prepared for sterile use prior to clinical application. This means it requires sterilization (e.g., via ethylene oxide, autoclave, or manufacturer-recommended methods) before insertion to maintain infection control standards during vascular procedures.
Are there multiple sizes or configurations available, and how do I determine which one to use for a specific procedure?
Yes, the Instylla Microcatheter comes in multiple lengths and diameters, as indicated by the extensive list of FEI numbers (e.g., 3012543881, 1018233). The appropriate size depends on the anatomical target and procedural requirements—such as the vessel diameter or depth of insertion. Consulting the manufacturer’s sizing guide or procedural protocols will help match the catheter to the specific case.
How is the regulatory pathway for this device structured, and what does the FDA 510(k) clearance indicate?
The Instylla Microcatheter received FDA 510(k) clearance (K191731) under the traditional review pathway, meaning it was determined to be substantially equivalent to legally marketed predicate devices. This clearance confirms the device meets FDA safety and effectiveness standards for its intended use in super selective vascular access, though it does not imply approval for specific clinical indications beyond what’s described in the device’s labeling.
Can the Instylla Microcatheter be reused, or is it intended for single-use only?
The device is explicitly labeled as single-use only, meaning it is not designed for reuse after a single procedure. Single-use catheters reduce infection risks and ensure consistent performance, which is particularly important in sterile vascular interventions where contamination could compromise patient safety.
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: Instylla Microcatheter (K191731) — FDA 510(k) | Innolitics, Instylla Microcatheter 1.2 by Instylla, Inc. | FDA 510 (k) Summary, PDF Instylla, Inc. Jennifer Greer Regulatory Affairs Manager
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K191731 | Class II | Active |
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Manufacturer
- Manufacturer
- Instylla, Inc.
Sources (1)
- FDA 510(k) K191731 24 fields · synced Sep 19, 2026