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510(k) K063061

CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 by Viasys Medsystems — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 2, 2007
Date Received
October 5, 2006
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 Viasys Medsystems

  • K081725 — ENTERAL PUMP SET, MODEL 20-1010 (November 7, 2008)
  • K080679 — MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 (June 27, 2008)
  • K043044 — ANTI-I.V. ENTERAL FEEDING SYSTEM (May 6, 2005)
  • K050309 — PULMANEX DISPOSABLE PRESSURE MANOMETER, MODEL 50-5000 (March 25, 2005)
  • K043004 — STACKHOUSE FREEDOMAIRE II SURGICAL HELMET SYSTEM, MODELS 12000, 12010, 12011, 12 (March 16, 2005)
  • K041987 — CORTRAK (December 17, 2004)

Other clearances for product code KNT

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  • K243228 — Flexi-Seal AIR (with ENFit Connector) (March 28, 2025)
  • K242336 — hygh-tec Drainage II (January 17, 2025)
  • K242901 — ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN (January 10, 2025)
  • 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)
  • K233591 — Stylus (May 31, 2024)
  • K241039 — ReShape Calibration Tubes (B-2032, B-2036, B-2040); ReShape Calibration Tubes (B (May 16, 2024)
  • K234033 — ViSiGi LUX (5332); ViSiGi LUX (5336); ViSiGi LUX (5340) (May 6, 2024)