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510(k) K041987

CORTRAK by Viasys Medsystems — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 2004
Date Received
July 23, 2004
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

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  • K080679 — MODIFICATION TO CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 (June 27, 2008)
  • K063061 — CORTRAK ENTERAL ACCESS DEVICE, MODEL 20-0900 (April 2, 2007)
  • 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)

Other clearances for product code KNT

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  • 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)