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Atrion Medical Balloon Catheter Inflation Device

FDA 510(k)

Class II (US FDA 510(k))

510(k) K972964

by Atrion Medical Products, Inc.

Identifiers

510(k) Number
K972964 FDA 510(k)
FDA Product Code
KOE FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 876.5520 FDA 510(k)
Regulation Number
876.5520 FDA 510(k)
Advisory Committee
Gastroenterology, Urology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Atrion Medical Balloon Catheter Inflation Device is a dilator, urethral (as classified by the OpenFDA nomenclature), designed for inflating balloon catheters during medical procedures. It facilitates controlled dilation of strictures or obstructions in the urethra or other tubular anatomical structures, enabling safe passage of fluids or instruments.

This device is supplied as a single-use, non-sterile inflation system and is intended for use in clinical settings such as urology and gastroenterology. It is classified under FDA regulation 876.5520 and holds a Traditional 510(k) clearance (K972964) for substantial equivalence. The device is not MRI-safe, and its configuration may vary to accommodate different catheter sizes or procedural requirements. Storage and handling follow standard medical device protocols.

Frequently asked questions

What clinical specialties is this device primarily intended for, and how does it support their procedures?

This device is designed for use in urology and gastroenterology, where controlled dilation of strictures or obstructions in tubular anatomical structures—such as the urethra—is required. It inflates balloon catheters to safely facilitate the passage of fluids or instruments, aiding procedures like urethral dilation or endoscopic interventions.

Is this device single-use or reusable, and what does that mean for clinical workflows?

The Atrion Medical Balloon Catheter Inflation Device is single-use only, meaning each unit is intended for one procedure and must not be reused. This design ensures sterility and safety, as reuse could compromise integrity and introduce contamination risks, requiring clinicians to prepare a new device for each case.

How does the device’s non-sterile status affect its handling and storage in a clinical setting?

Since the device is non-sterile, it must be sterilized by the user before use via standard medical sterilization protocols (e.g., autoclaving or ethylene oxide). Storage should follow clinical guidelines for non-sterile medical devices, typically in a clean, dry environment away from direct sunlight or extreme temperatures, to maintain functionality until sterilization.

Does this device accommodate different catheter sizes, and if so, how might that impact selection for a procedure?

Yes, the device is configured to work with multiple catheter sizes, as indicated by its classification under OpenFDA’s urethral dilator category and its use in both urology and gastroenterology. Clinicians should verify compatibility with the specific catheter being used, as the inflation system’s design may vary to ensure proper dilation without overinflation or leakage.

What safety considerations should clinicians be aware of when using this device, particularly regarding MRI compatibility?

This device is not MRI-safe, meaning it should never be used or stored in an MRI environment. Additionally, its materials and construction are optimized for controlled dilation, so improper use—such as overinflation or rapid deflation—could damage tissue or the catheter. Always follow manufacturer instructions and procedural protocols to mitigate risks.

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: Atrion Medical Devices, Atrion QL® Inflation Devices - Nordson MEDICAL, PDF INFLATION DEVICES - Atrion Medical, Balloon catheter inflation device - Atrion Medical

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Atrion Medical Products, Inc.

Sources (1)

  • FDA 510(k) K972964 24 fields · synced Oct 6, 2026