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510(k) K895650

ENTERAL PUMP SET W/ENTERA-FLO SPIKE by Delmed, Inc. — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 2, 1990
Date Received
September 20, 1989
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 Delmed, Inc.

  • K895142 — ENTERAL PUMP SET WITH ENTERAL SPIKE (October 2, 1990)
  • K895329 — 600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA (October 2, 1990)
  • K894506 — ENTERA-FLO ENTERAL FEEDING PUMP (August 6, 1990)
  • K901478 — DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTION (July 27, 1990)
  • K901477 — DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION (July 27, 1990)
  • K900106 — CLOSED DISCONNECT SYSTEM (July 16, 1990)
  • K895919 — ENTERAL BAG ADMINI. SETS FOR USE W/FLEXIFLO-III (May 2, 1990)
  • K895933 — ENTERAL PUMP SETS FOR USE WITH ROSS FLEXIFLO-III (May 2, 1990)
  • K895246 — FRENTA(R) DUO-SET (May 2, 1990)
  • K895330 — 600ML AND 1200ML ENTERAL BAG ADM. SET FOR FRENTA (May 2, 1990)

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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)
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  • 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)