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510(k) K102548

FOOTPRINT MEDICAL POLYURETHANE FEEDING TUBE by Footprint Medical, Inc. — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 26, 2010
Date Received
September 3, 2010
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Tubes, Gastrointestinal (And Accessories)
Device Class
Class II
Regulation Number
876.5980
Review Panel
GU
Submission Type

Other clearances by Footprint Medical, Inc.

  • K130507 — FOOTPRINT MEDICAL POLYURETHANE PICC CATHETER (June 3, 2013)
  • K120304 — FOOTPRINT MEDICAL POLYURETHANE UMBILICAL CATHETER (March 1, 2012)
  • 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)
  • K091214 — FOOTPRINT MEDICAL SILICONE UMBILICAL CATHETER (September 25, 2009)
  • K091488 — FOOTPRINT MEDICAL PERIPHERALLY INSERTED CENTRAL CATHETER, MODEL S1PIC1.9-C (September 14, 2009)
  • K090576 — FOOTPRINT URINARY DRAINAGE CATHETER (August 12, 2009)
  • K090559 — FOOTPRINT MEDICAL SILICONE FEEDING TUBE (May 4, 2009)

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  • K241169 — Entarik NI Feeding Tube System (November 22, 2024)
  • K241185 — CORGRIP* SR NG/NI Tube Retention System (October 25, 2024)
  • K240965 — CORTRAK* 2 Enteral Access System (20-0950) (June 6, 2024)
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  • K241039 — ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B (May 16, 2024)
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