Device Atlas

Vista Scientific Barium Sulfate, Model 3001-1

Q: What is the product code of K024359?

The FDA product code is MYU – Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty, a Class II (moderate risk) device regulated under 21 CFR 882.5300.

FDA 510(k) K024359 · Vista Scientific, LLC

Substantially Equivalent

510(k) numberK024359

Submission

Device name: Vista Scientific Barium Sulfate, Model 3001-1
Applicant: Vista Scientific, LLC
Niwot, CO, US
Received: December 30, 2002
Decision date: August 8, 2003
Decision: Substantially Equivalent (SESE)
Type: Abbreviated 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: MYU – Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty
Device class: Class II (moderate risk)
Regulation: 21 CFR 882.5300
Specialty: Neurology
Implant: Yes

Other 510(k)s with product code MYU

510(k)	Device	Applicant	Decision
K033230	Tracers Ta Bone Cement Opacifier, Model Tcr-TaMYU · Special	Parallax Medical, Inc.	12/12/2003SE
K032388	Bone Cement Radio-OpacifierMYU · Traditional	Cardinalhealth	10/31/2003SE
K023445	Tracers Bone Cement OpacifierMYU · Special	Parallax Medical, Inc.	03/11/2003SE
K002063	Biotrace, Model 1730MYU · Traditional	Bryan Corp.	08/10/2000SE
K991893	Parallax Tracer Radiopaque ParticlesMYU · Traditional	Parallax Medical, Inc.	08/13/1999SE

Questions and answers

When was Vista Scientific Barium Sulfate, Model 3001-1 cleared by the FDA?

Vista Scientific Barium Sulfate, Model 3001-1 (K024359) received a 510(k) decision of Substantially Equivalent on August 8, 2003, 221 days after the submission was received.

What is the product code of K024359?

The FDA product code is MYU – Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty, a Class II (moderate risk) device regulated under 21 CFR 882.5300.