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510(k) K991893

PARALLAX TRACER RADIOPAQUE PARTICLES by Parallax Medical, Inc. — Product Code MYU

K991893 is an FDA 510(k) premarket notification submitted by Parallax Medical, Inc. for the device "PARALLAX TRACER RADIOPAQUE PARTICLES". The FDA issued a decision of Substantially Equivalent on August 13, 1999. The device falls under product code MYU (Accessory, Barium Sulfate, Methyl Methacrylate For Cranioplasty), a Class II device regulated under 21 CFR 882.5300. Parallax Medical, Inc. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1999
Date Received
June 3, 1999
Clearance Type
Traditional
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 by Parallax Medical, Inc.

  • K033230 — TRACERS TA BONE CEMENT OPACIFIER, MODEL TCR-TA (December 12, 2003)
  • K023445 — TRACERS BONE CEMENT OPACIFIER (March 11, 2003)
  • K022169 — CLEARVIEW PLUS BONE AND VERTEBRAL BODY BIOPSY NEEDLES (July 25, 2002)
  • K011206 — PARALLAX BONE AND VERTEBRAL BODY BIOPSY AND INFUSION NEEDLES (July 18, 2001)
  • K994022 — PARALLAX CRANIOSET (August 31, 2000)

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)
  • K024359 — VISTA SCIENTIFIC BARIUM SULFATE, MODEL 3001-1 (August 8, 2003)
  • K023445 — TRACERS BONE CEMENT OPACIFIER (March 11, 2003)
  • K002063 — BIOTRACE, MODEL 1730 (August 10, 2000)

FDA data resources