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Kerberos Proximal Solutions RISPIRATION System

by Kerberos Proximal Solutions, Inc.

510(k) K050130

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESU Traditional NumberK050130 Date13 May 2005ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
QEZ
Device Class
Class II
Regulation
21 CFR Part 870.5150
Advisory Committee
Cardiovascular
FDA Decision
SESU

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Kerberos Proximal Solutions RISPIRATION System is an aspiration thrombectomy catheter designed to infuse physician-specified fluid and remove fresh, soft emboli and thrombi from the coronary and peripheral vasculature. It functions as a proximal embolic protection device to recover debris dislodged during angioplasty and stent placement procedures.

The device is used in cardiovascular settings for coronary and peripheral vascular interventions. It is supplied as a single-use system and is regulated under FDA 510(k) clearance with product code QEZ and regulation number 870.5150. The system is intended for sterile, single-use application and must be stored in a dry, controlled environment prior to use.

Other devices from Kerberos Proximal Solutions, Inc.

Questions

AI-generated answers, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Kerberos RISPIRATION System used for?

    It is an aspiration thrombectomy catheter designed to infuse physician-specified fluid and remove fresh, soft emboli and thrombi from the coronary and peripheral vasculature. It also functions as a proximal embolic protection device to recover debris dislodged during angioplasty and stent placement procedures.

  • How is the device supplied and can it be reused?

    The system is supplied as a single-use device. It is intended for sterile, single-use application only and must not be reused or resterilized.

  • What are the storage requirements for this device?

    The device must be stored in a dry, controlled environment prior to use. Proper storage helps maintain sterility and integrity of the single-use system.

  • What regulatory pathway was used for this device?

    The device was cleared through the FDA 510(k) premarket notification pathway under product code QEZ and regulation number 870.5150. It is classified as a Class II medical device.

  • What clinical specialties use this device?

    It is primarily used in cardiovascular settings by interventional cardiologists and vascular surgeons for coronary and peripheral vascular interventions, including angioplasty and stent placement procedures.