Parallax Tracer Radiopaque Particles

FDA 510(k) K991893 · Parallax Medical, Inc.

Substantially Equivalent

510(k) numberK991893

Submission

Device name
Parallax Tracer Radiopaque Particles
Applicant
Parallax Medical, Inc.
Mountain View, CA, US
Received
June 3, 1999
Decision date
August 13, 1999
Decision
Substantially Equivalent (SESE)
Type
Traditional 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)DeviceApplicantDecision
K033230Tracers Ta Bone Cement Opacifier, Model Tcr-TaMYU · Special Parallax Medical, Inc.12/12/2003SE
K032388Bone Cement Radio-OpacifierMYU · Traditional Cardinalhealth10/31/2003SE
K024359Vista Scientific Barium Sulfate, Model 3001-1MYU · Abbreviated Vista Scientific, LLC08/08/2003SE
K023445Tracers Bone Cement OpacifierMYU · Special Parallax Medical, Inc.03/11/2003SE
K002063Biotrace, Model 1730MYU · Traditional Bryan Corp.08/10/2000SE

More from Bryan Corp.

510(k)DeviceDecision
K033230Tracers Ta Bone Cement Opacifier, Model Tcr-TaMYU · Special 12/12/2003SE
K023445Tracers Bone Cement OpacifierMYU · Special 03/11/2003SE
K022169Clearview Plus Bone and Vertebral Body Biopsy NeedlesKNW · Special 07/25/2002SE
K011206Parallax Bone and Vertebral Body Biopsy and Infusion NeedlesKNW · Abbreviated 07/18/2001SE
K994022Parallax CraniosetGXP · Traditional 08/31/2000SE

Questions and answers

When was Parallax Tracer Radiopaque Particles cleared by the FDA?

Parallax Tracer Radiopaque Particles (K991893) received a 510(k) decision of Substantially Equivalent on August 13, 1999, 71 days after the submission was received.

What is the product code of K991893?

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.