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510(k) K063795

GUARDIANCATHETER-URINARY DRAINAGE CATHETER by Marian Medical, Inc. — Product Code GBM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 2007
Date Received
December 22, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Urethral
Device Class
Class II
Regulation Number
876.5130
Review Panel
GU
Submission Type

Other clearances by Marian Medical, Inc.

  • K070048 — GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT (March 15, 2007)
  • K050542 — MARIAN INFANT FEEDING TUBE (GUARDIANPICC PERCUTANEOUS CENTRAL VENOUS CATHETER (July 26, 2005)
  • K042112 — INFANT FEEDING TUBE (January 28, 2005)

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