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Stockert-Shiley Double Head Pump Module

by Shiley, Inc. 510(k)

Active United States

510(k) K862116

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK862116 Date16 Jul 1986ClearedStatusActive

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  • Withdrawn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
DWB
Device Class
Class II
Regulation
21 CFR Part 870.4370
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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