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Fst Cath Ud-Dual Dual Pressure Catheter

by Fiberoptic Sensor Technlogies, Inc. 510(k)

Active United States

510(k) K926088

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK926088 Date18 Jun 1993ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
FEN
Device Class
Class II
Regulation
21 CFR Part 876.1620
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

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