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Catco Nutritional Catheter

by Catco Medical, Inc.

510(k) K945012

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK945012 Date24 Feb 1995ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
KNT
Device Class
Class II
Regulation
21 CFR Part 876.5980
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Catco Nutritional Catheter is a gastrointestinal tube device used for enteral feeding. It is a single lumen catheter designed for nutritional support through the gastrointestinal tract.

This device is supplied by Catco Medical, Inc. and is cleared by the FDA under 510(k) number K945012 with product code KNT. It is classified under Tubes, Gastrointestinal (and Accessories) and reviewed by the Gastroenterology/Urology panel. The device was received by the FDA on October 13, 1994, and cleared as substantially equivalent on February 24, 1995.

Other devices from Catco Medical, Inc.

See all devices from Catco Medical, Inc. →

Questions

AI-generated answers, 28 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the Catco Nutritional Catheter used for?

    The Catco Nutritional Catheter is a gastrointestinal tube device specifically designed for enteral feeding, providing nutritional support through the gastrointestinal tract.

  • Is the Catco Nutritional Catheter single-use or reusable?

    The Catco Nutritional Catheter is designed as a single-use device for enteral feeding through the gastrointestinal tract, ensuring patient safety and hygiene.

  • What regulatory approvals does the Catco Nutritional Catheter have?

    The Catco Nutritional Catheter is cleared by the FDA under 510(k) number K945012 with product code KNT, classified under Tubes, Gastrointestinal (and Accessories).

  • How is the Catco Nutritional Catheter supplied?

    The Catco Nutritional Catheter is supplied by Catco Medical, Inc., a medical device manufacturer based in San Antonio, Texas.