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510(k) K090576

FOOTPRINT URINARY DRAINAGE CATHETER by Footprint Medical — Product Code EZD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 12, 2009
Date Received
March 3, 2009
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K093026 — FOOTPRINT MEDICAL 1.9 FR PICC INTRODUCER (February 24, 2010)
  • K093252 — FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER (December 17, 2009)
  • K091213 — FOOTPRINT MEDICAL UMBILICAL CATHETER, DUAL LUMEN (September 25, 2009)
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  • K091488 — FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER, MODEL S1PIC1.9-C (September 14, 2009)
  • K090559 — FOOTPRINT MEDICAL SILICONE FEEDING TUBE (May 4, 2009)

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