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510(k) K050542

MARIAN INFANT FEEDING TUBE (GUARDIANPICC PERCUTANEOUS CENTRAL VENOUS CATHETER by Marian Medical, Inc. — Product Code LJS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 26, 2005
Date Received
March 2, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days
Device Class
Class II
Regulation Number
880.5970
Review Panel
HO
Submission Type

Other clearances by Marian Medical, Inc.

  • K070048 — GUARDIAN CATHETER-INFANT URINARY COLLECTION KIT (March 15, 2007)
  • K063795 — GUARDIANCATHETER-URINARY DRAINAGE CATHETER (March 5, 2007)
  • K042112 — INFANT FEEDING TUBE (January 28, 2005)

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