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510(k) K851299

CORRECT FLO by Norton Performance Plastics Corp. — Product Code FPA

K851299 is an FDA 510(k) premarket notification submitted by Norton Performance Plastics Corp. for the device "CORRECT FLO". The FDA issued a decision of Substantially Equivalent on May 7, 1985. The device falls under product code FPA (Set, Administration, Intravascular), a Class II device regulated under 21 CFR 880.5440. Norton Performance Plastics Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 7, 1985
Date Received
April 1, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Set, Administration, Intravascular
Device Class
Class II
Regulation Number
880.5440
Review Panel
HO
Submission Type

Other clearances by Norton Performance Plastics Corp.

  • K853791 — NORTON CARDIOPLEGIC QUICK COOLING COIL 421738-000 (December 9, 1985)
  • K852914 — ANGIOGRAPHIC, WEDGE PRESS, DUAL THERMOD & INFUSION (September 25, 1985)
  • K842858 — FLUID ADMINISTRATION LINE W/SPIKE 14-923 (September 11, 1984)
  • K841828 — CENTRAL VENOUS CATHETER W/BIG-GARD (July 13, 1984)
  • K840240 — MICROFUSE INTRAVENOUS CATHETER SET (April 17, 1984)
  • K831587 — TEMP. REPAIR KIT-DUAL LUMEN CATHETER (October 19, 1983)
  • K831698 — DISPOSABLE PRESSURE TRANSDUCER#14004195 (August 11, 1983)
  • K830788 — CENTRAL VEIN CATHERIZATION KIT-14-690- (April 30, 1983)
  • K830813 — FRENCH PERCUTANEOUS SHEATH INTRODUCER (April 28, 1983)
  • K830969 — PERM. REPAIR KIT FOR LEONARD NORTON DUAL (April 14, 1983)

Other clearances for product code FPA

  • K254123 — Ecomed Disposable Administration Sets (September 11, 2026)
  • K261530 — iiSure Infusion Set (June 3, 2026)
  • K252543 — AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, (May 4, 2026)
  • K251375 — PuraCath Firefly Needleless Connector IT (9005) (February 12, 2026)
  • K251257 — nSet+ Stabilization Set [6426733]; nSet+ Stabilization Set with nSyte Needle Fre (December 4, 2025)
  • K250325 — BD Alaris Pump Infusion Set (October 30, 2025)
  • K251814 — EZ™ IV Administration Set (August 29, 2025)
  • K251854 — SteadiSet infusion set (August 6, 2025)
  • K243841 — Sparta Infusion Set for Insulin (August 1, 2025)
  • K243392 — Infusomat® Space Volumetric Infusion Pump Administration Sets (July 24, 2025)

FDA data resources