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510(k) K922567

LOW PROFILE CATHETER by Rusch, Inc. — Product Code KNT

Clearance Details

Decision
SESK (Substantially Equivalent (kit))
Decision Date
November 21, 1995
Date Received
June 1, 1992
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 Rusch, Inc.

  • K010420 — RUSCH MMG/O'NEIL CATHETER (May 9, 2001)
  • K993528 — RUSCH EMERGENCY MASK (May 31, 2000)
  • K993194 — RUSCH MANUAL RESUSCITATOR BAG (March 24, 2000)
  • K980870 — RUSCH SILICONE FOLEY CATHETER (June 9, 1998)
  • K974419 — RUSCH SIMPLASTIC COUNCILL TIP CATHETER (January 27, 1998)
  • K963779 — RUSCH ENTERAL FEEDING TUBE (May 23, 1997)
  • K970021 — RUSCH SUPRAPUBIC TRAY (February 7, 1997)
  • K963993 — RUSCH SIMPLASTIC FOLEY CATHETERIZATION SET (December 17, 1996)
  • K955564 — RUSCH ULTRA TRACHEOFLEX TRACHEOSTOMY SET, CUFFED, STERILE (June 28, 1996)
  • K955495 — RUSCH REINFORCED TRACHAEL TUBE CUFFED, STERILE (June 27, 1996)

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)