← Back to catalogue

Pump Tubing With X-Coating

FDA 510(k)

Class II (US FDA 510(k))

510(k) K003371

by Terumo Corp.

Identifiers

510(k) Number
K003371 FDA 510(k)
FDA Product Code
DWF FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.4210 FDA 510(k)
Regulation Number
870.4210 FDA 510(k)
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Pump Tubing With X-Coating by Terumo Corp. — Class II — FDA_510K — listed in FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Terumo Corp.

Sources (1)

  • FDA 510(k) K003371 24 fields · synced Jun 18, 2026