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510(k) K913397

MEGA ANGIOGRAM KIT by Mega Medical, Inc. — Product Code DQO

Clearance Details

Decision
SEKD (Substantially Equivalent (kit, denovo))
Decision Date
October 31, 1991
Date Received
July 30, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Diagnostic
Device Class
Class II
Regulation Number
870.1200
Review Panel
CV
Submission Type

Other clearances by Mega Medical, Inc.

  • K915863 — MEGA AMNIOCENTESIS KIT (March 30, 1992)
  • K913317 — MEGA ARTHROGRAM KIT (October 31, 1991)
  • K912445 — MEGA CONTINUOUS EPIDURAL ANESTHESIA KIT (October 18, 1991)
  • K913382 — MEGA PARACENTESIS KIT (October 8, 1991)
  • K912322 — MEGA SPINAL ANESTHESIA KIT (September 26, 1991)
  • K912564 — MEGA PERICARDIOCENTESIS KIT (September 5, 1991)

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