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Greco-Harvey Surfactant Bonded Catheter for Cardio

FDA 510(k)

Class II (US FDA 510(k))

510(k) K851241

by Cook, Inc.

Identifiers

510(k) Number
K851241 FDA 510(k)
FDA Product Code
DQY 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 Greco-Harvey Surfactant Bonded Catheter for Cardio is a percutaneous catheter designed for cardiovascular procedures. It features a surfactant-bonded surface intended to reduce biofouling, enhancing durability and performance during use. This device falls under the classification of Catheter, Percutaneous (Product Code DQY) and is intended for insertion and manipulation within the cardiovascular system.

This catheter is supplied as a single-use, sterile device and is regulated under FDA 510(k) clearance (K851241) with a Traditional review pathway. It was originally submitted to the FDA in 1985 and cleared in 1986 under the Cardiovascular Advisory Committee. The device adheres to Class II Special Controls and is intended for use in controlled clinical settings where cardiovascular interventions are performed.

Frequently asked questions

What is the Greco-Harvey Surfactant Bonded Catheter for Cardio used for?

This catheter is designed for percutaneous insertion and manipulation within the cardiovascular system. Its surfactant-bonded surface helps minimize biofouling, which can extend its functional lifespan during procedures like angiography, cardiac catheterization, or other interventional cardiology applications. The bonding reduces protein adhesion, improving reliability in controlled clinical settings.

Is the Greco-Harvey Surfactant Bonded Catheter single-use or reusable?

The device is explicitly supplied as a single-use catheter. This design choice ensures sterility and safety for one-time use per patient, reducing the risk of cross-contamination or degradation from repeated sterilization processes. Single-use also aligns with clinical best practices for percutaneous catheters.

How is the catheter supplied, and what sterility assurances does it provide?

The Greco-Harvey Surfactant Bonded Catheter is supplied sterile and ready for immediate use. Sterility is maintained through manufacturer-controlled processes, ensuring it meets regulatory standards for medical devices intended for direct patient contact. The packaging is designed to preserve sterility until the first use.

What regulatory pathway was followed for FDA clearance of this catheter?

The device underwent a Traditional 510(k) review process and was cleared by the FDA in 1986 under the Cardiovascular Advisory Committee. It was originally submitted in 1985 and classified under Product Code DQY (Catheter, Percutaneous). The clearance was based on a determination of substantial equivalence to a predicate device, adhering to Class II Special Controls.

Are there different sizes or models available for this catheter?

The provided data does not specify multiple sizes or models for the Greco-Harvey Surfactant Bonded Catheter. However, like many percutaneous catheters, variations in length, diameter, or lumen configuration may exist to accommodate different patient anatomies or procedural needs. For exact specifications, consult the manufacturer’s technical documentation or catalog.

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: greco-harvey surfactant bonded catheter for cardio, K851241 FDA 510(k) - GRECO-HARVEY SURFACTANT BONDED CATHETER..., Greco-harvey Surfactant Bonded Catheter for Cardio, K851244 FDA 510(k) - GRECO-HARVEY SURFACTANT BONDED CATH FOR...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Cook, Inc.

Sources (1)

  • FDA 510(k) K851241 24 fields · synced Oct 6, 2026