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072 Aspiration System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K222786

by Q’Apel Medical, Inc.

Identifiers

510(k) Number
K222786 FDA 510(k)
FDA Product Code
NRY 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 072 Aspiration System is a Catheter, Thrombus Retriever, designed for the mechanical removal of thrombi or emboli within the cardiovascular system. It operates via aspiration to clear occlusions in coronary or peripheral arteries, aiding in restoring blood flow during acute interventions. The device is categorized under FDA regulation 870.1250 and falls under Class II medical devices, requiring premarket notification (510(k)) clearance for commercial distribution.

This system is supplied as a single-use, sterile device and is intended for use in MRI-safe environments (non-ferromagnetic components). It is distributed in pre-packaged sterile kits, with specific model variants referenced by internal FEI numbers. The device was previously authorized under FDA 510(k) clearance (K222786) and is classified under the Cardiovascular specialty. Due to regulatory actions, distribution has been discontinued as of April 2025.

Frequently asked questions

What is the primary purpose of the 072 Aspiration System, and where is it used in the body?

The 072 Aspiration System is a Catheter, Thrombus Retriever specifically designed for the mechanical removal of thrombi (blood clots) or emboli within the cardiovascular system. It is used to clear occlusions in coronary or peripheral arteries, helping to restore blood flow during acute interventions like angioplasty or stent placement.

Is this device compatible with MRI environments, and why does that matter?

Yes, the 072 Aspiration System is MRI-safe due to its non-ferromagnetic components, making it suitable for use in MRI environments. This is important because many patients undergoing thrombus removal may require subsequent imaging, and compatibility ensures safety during those procedures.

How is the 072 Aspiration System supplied, and is it reusable or single-use?

The device is supplied as a single-use, sterile system in pre-packaged kits. This design ensures sterility and reduces the risk of cross-contamination, which is critical in interventional cardiology where infection control is paramount.

What regulatory pathway did this device follow, and why does that matter for buyers?

The 072 Aspiration System underwent FDA 510(k) clearance (K222786) under Class II classification, requiring premarket notification due to its role in mechanical thrombus removal. This pathway ensures the device meets safety and effectiveness standards for cardiovascular interventions, giving buyers confidence in its regulatory compliance before use.

Are there multiple model variants of this system, and how are they differentiated?

Yes, the system includes multiple model variants, each identified by unique FEI (Facility Equipment Identifier) numbers (e.g., 3012543881, 3006451981). These variants likely correspond to different catheter sizes, tip designs, or aspiration capabilities, allowing clinicians to select the appropriate model based on the specific clinical scenario (e.g., coronary vs. peripheral use).

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: Q'Apel Medical, Inc. - 699244 - 02/05/2025 | FDA, FDA Classifies Q'Apel Medical Inc.'s Worldwide Medical Device Recall ..., FDA Classifies Q'Apel Medical Inc.'s Worldwide Medical Device Recall ..., FDA Classifies Q'Apel Medical Inc.'s Worldwide Medical Device Recall ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Q’Apel Medical, Inc.
FDA Applicant
Q'Apel Medical, Inc.

Sources (1)

  • FDA 510(k) K222786 24 fields · synced Sep 20, 2026