Skip to content

Perfusion Tubing Set

by Shiley, Inc. 510(k)

Active United States

510(k) K760922

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK760922 Date19 Nov 1976ClearedStatusActive

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  • Withdrawn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 10 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
KDL
Device Class
Class II
Regulation
21 CFR Part 876.5880
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Other devices from Shiley, Inc.

See all devices from Shiley, Inc. →