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FlowGuide (FG60F); GuidionShort (GS60F)

FDA 510(k)

Class II (US FDA 510(k))

510(k) K242337

by IMDS Operations B.V.

Identifiers

510(k) Number
K242337 FDA 510(k)
FDA Product Code
DQY FDA 510(k)
Models / Variants
FlowGuide (FG60F) FDA 510(k)
GuidionShort (GS60F) FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1250 FDA 510(k)
Regulation Number
870.1250 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The FlowGuide (FG60F) and GuidionShort (GS60F) are percutaneous catheters designed for guiding and supporting interventional procedures within the cardiovascular system. These devices assist in the precise placement of guidewires, catheters, or other instruments during coronary interventions, enhancing procedural accuracy and safety.

Supplied as single-use devices, the FlowGuide (FG60F) and GuidionShort (GS60F) are intended for use in controlled clinical settings such as catheterization laboratories. They are classified under product code DQY and fall under the regulatory category of Class II devices, with clearance through the FDA 510(k) pathway as substantially equivalent. Storage and handling must comply with sterile medical device protocols to ensure integrity prior to use.

Frequently asked questions

Are the FlowGuide (FG60F) and GuidionShort (GS60F) catheters reusable or designed for single-use only?

The FlowGuide (FG60F) and GuidionShort (GS60F) catheters are explicitly supplied as single-use devices. This design ensures sterility and safety for controlled clinical settings like catheterization laboratories, where each procedure requires a sterile instrument to minimize infection risks and maintain procedural integrity.

What types of cardiovascular procedures are these catheters intended to assist with, and how do they improve accuracy?

These catheters—FlowGuide (FG60F) and GuidionShort (GS60F)—are percutaneous catheters designed to guide and support interventional procedures within the cardiovascular system. They assist in the precise placement of guidewires, catheters, or other instruments during coronary interventions, enhancing procedural accuracy and safety by providing structural support and stability during placement.

How should these catheters be stored to maintain their sterility before use?

Since the FlowGuide (FG60F) and GuidionShort (GS60F) are sterile single-use devices, they must be stored and handled according to sterile medical device protocols. This includes keeping them in their original packaging, away from contamination, and following manufacturer guidelines to preserve sterility until immediate use in a controlled clinical environment like a catheterization lab.

What regulatory pathway was used to clear these catheters, and what does that mean for their use?

The FlowGuide (FG60F) and GuidionShort (GS60F) were cleared through the FDA 510(k) pathway, specifically under the substantially equivalent (SESE) decision. This means the FDA determined they are as safe and effective as a legally marketed predicate device, allowing their use in controlled clinical settings (e.g., catheterization labs) for guiding cardiovascular interventions as described in their labeling.

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: FlowGuide (FG60F); GuidionShort (GS60F) (K242337) — FDA 510 (k ..., flowguide fg60f guidionshort gs60f - Imds Operations | FDA Evidence Review, K242337 - FlowGuide (FG60F) - FDA 510 (k)

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
IMDS Operations B.V.

Sources (1)

  • FDA 510(k) K242337 24 fields · synced Sep 20, 2026