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510(k) K024359

VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1 by Vista Scientific, LLC — Product Code MYU

K024359 is an FDA 510(k) premarket notification submitted by Vista Scientific, LLC for the device "VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1". The FDA issued a decision of Substantially Equivalent on August 8, 2003. The device falls under product code MYU (Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty), a Class II device regulated under 21 CFR 882.5300.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 8, 2003
Date Received
December 30, 2002
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty
Device Class
Class II
Regulation Number
882.5300
Review Panel
NE
Submission Type

Other clearances for product code MYU

  • K033230 — TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA (December 12, 2003)
  • K032388 — BONE CEMENT RADIO-OPACIFIER (October 31, 2003)
  • K023445 — TRACERS BONE CEMENT OPACIFIER (March 11, 2003)
  • K002063 — BIOTRACE, MODEL 1730 (August 10, 2000)
  • K991893 — PARALLAX TRACER RADIOPAQUE PARTICLES (August 13, 1999)

FDA data resources