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Tygon Tubing

by Electromedics, Inc.

510(k) K803277

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

1 ongoing

Recall on shared 510(k) K803277; other models may be affected

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 NumberK803277 Date13 Jan 1981ClearedStatusActive

Recalls

1 recall · 1 ongoing · FDA

    • Ongoing Z-0785-2019 FDA Class II initiated 27 Nov 2018 on shared 510(k) K803277

    Medtronic discovered that certain Y-connectors included in the suction lines have exhibited tearing and cracking. These defects could cause the Y-connectors to leak when in use, which could result in potential blood loss and a breach in the circuit.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

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  • Withdrawn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
DWE
Device Class
Class II
Regulation
21 CFR Part 870.4390
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

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