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Recovery Filter System, Model RF-048F

FDA 510(k)

Class II (US FDA 510(k))

510(k) K031328

by C. R. Bard, Inc.

Identifiers

510(k) Number
K031328 FDA 510(k)
FDA Product Code
DTK FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.3375 FDA 510(k)
Regulation Number
870.3375 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Recovery Filter System, Model RF-048F is an intravascular cardiovascular filter. It is designed to function as a filter within the cardiovascular system.

This device is classified as a Class II medical device under regulation number 870.3375. It has received FDA 510(k) clearance.

Frequently asked questions

What is the primary function of the Recovery Filter System, Model RF-048F?

The Recovery Filter System, Model RF-048F, is designed to function as an intravascular cardiovascular filter within the cardiovascular system.

What is the regulatory status of this device?

The Recovery Filter System, Model RF-048F, is classified as a Class II medical device under regulation number 870.3375 and has received FDA 510(k) clearance.

Who is the manufacturer of the RF-048F filter system?

The device is manufactured by C. R. Bard, Inc., located in Tempe, Arizona.

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: RECOVERY FILTER SYSTEM, MODEL RF-048F (K022236) — FDA 510(k ..., RECOVERY FILTER SYSTEM, MODEL RF-048F (K022236) - FDA 510 (k), K031328 FDA 510(k) - RECOVERY FILTER SYSTEM | C.R. Bard, Inc.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
C. R. Bard, Inc.
FDA Applicant
C.R. Bard, Inc.

Sources (1)

  • FDA 510(k) K031328 24 fields · synced Sep 23, 2026