MEDRAD Imaging Bulk Package Transfer Spike

by Bayer Medical Care Inc. 510(k)

Active United States

510(k) K200280

Regulatory status

as of 29 Oct 2026

Region	Authorization	Number	Date	Status
United States	FDA 510(k)SESE Substantially Equivalent · Traditional	NumberK200280	Date30 Jul 2020Cleared	StatusActive

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 11 Oct 2026.

Specification

510(k)

510(k) Number: K200280
FDA Product Code: PQH
FDA applicant: Bayer Medical Care, Inc.

Device Class: Class II
Regulation: 21 CFR Part 880.5440
Advisory Committee: General Hospital
FDA Decision: SESE Substantially Equivalent

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