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510(k) K893209

ENTERA-FLO SPIKE SET by Delmed, Inc. — Product Code KNT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 1989
Date Received
April 27, 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.

  • K895650 — ENTERAL PUMP SET W/ENTERA-FLO SPIKE (October 2, 1990)
  • K895329 — 600ML AND 1200ML ENTERAL BAG ADM. SET FOR ENTERA (October 2, 1990)
  • K895142 — ENTERAL PUMP SET WITH ENTERAL SPIKE (October 2, 1990)
  • K894506 — ENTERA-FLO ENTERAL FEEDING PUMP (August 6, 1990)
  • K901477 — DELMED 80/2 DIALYSIS SYSTEM W/ULTRAFILTRATION (July 27, 1990)
  • K901478 — DELMED 80/2 DIALYSIS SYSTEM W/LAST BAG OPTION (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)

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)