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Medrad Intego Pet Infusion System

by Medrad, Inc.

510(k) K080297

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

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 NumberK080297 Date17 Jun 2008ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0400-2017 FDA Class II initiated 30 Sep 2016

    The Source Administration Sets (SAS) used with the Medrad Intego PET Infusion System do not meet pressure testing specifications in an occlusion situation when the product is more than one year past manufacturing date.

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  • Withdrawn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
FRN
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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