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ScoutPro Hemostatic Valve

FDA 510(k)

Class II (US FDA 510(k))

510(k) K101282

by Biotronik, Inc.

Identifiers

510(k) Number
K101282 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 ScoutPro Hemostatic Valve is a percutaneous catheter device designed to manage blood flow during interventional procedures. It functions as a hemostatic valve to maintain a seal around catheters or guidewires while allowing for device manipulation.

This device is classified as a Class II medical device under product code DQY. It has received FDA 510(k) clearance as documented under K101282. The valve is intended for use in cardiovascular clinical settings as specified by the manufacturer.

Frequently asked questions

What is the primary function of the ScoutPro Hemostatic Valve?

The ScoutPro Hemostatic Valve is designed for use in cardiovascular clinical settings to manage blood flow during interventional procedures. It functions by maintaining a secure seal around catheters or guidewires, which allows clinicians to manipulate devices while minimizing blood loss.

What is the regulatory status of this device?

The ScoutPro Hemostatic Valve has received FDA 510(k) clearance, documented under K101282. It is classified as a Class II medical device under product code DQY, indicating it has been found substantially equivalent to predicate devices for its intended use.

In what clinical environment is this valve used?

This device is intended for use specifically within cardiovascular clinical settings. It is designed to support percutaneous catheter procedures where maintaining a seal around inserted equipment is necessary for procedural safety and blood flow management.

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: K101282 FDA 510(k) - SCOUTPRO HEMOSTATIC VALVE | Biotronik, Inc., BIOTRONIK ScoutPro Hemostatic Valve - Technical manual, SCOUTPRO HEMOSTATIC VALVE (K101282) — FDA 510(k) | Innolitics

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Biotronik, Inc.

Sources (1)

  • FDA 510(k) K101282 24 fields · synced Sep 26, 2026