Truline Reinforced Valved Infusion Catheter

FDA 510(k)

Class II (US FDA 510(k))

510(k) K021139

Identifiers

510(k) Number: K021139 FDA 510(k)
FDA Product Code: FOZ FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 880.5200 FDA 510(k)
Regulation Number: 880.5200 FDA 510(k)
Advisory Committee: General Hospital FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The TRULINE REINFORCED VALVED INFUSION CATHETER is a high-quality, FDA-approved medical device designed for the minimally invasive placement of reinforced valves in various surgical procedures. It offers enhanced patient outcomes and improved surgical outcomes.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K021139	Class II	Active

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Manufacturer

Manufacturer: Micro Therapeutics, Inc.

Sources (1)

FDA 510(k) K021139 24 fields · synced Jul 12, 2026