Steripath Micro Blood Collection System

Q: What is the product code of K200661?

The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.

FDA 510(k) K200661 · Magnolia Medical Technologies, Inc.

Substantially Equivalent

510(k) numberK200661

Submission

Device name: Steripath Micro Blood Collection System
Applicant: Magnolia Medical Technologies, Inc.
Seattle, WA, US
Received: March 12, 2020
Decision date: October 8, 2020
Decision: Substantially Equivalent (SESE)
Type: Special 510(k)
Summary: 510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code: FPA – Set, Administration, Intravascular
Device class: Class II (moderate risk)
Regulation: 21 CFR 880.5440
Specialty: General Hospital

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More from B.Braun Medical, Inc.

510(k)	Device	Decision
K251812	Steripath® Flow Blood Collection SystemJKA · Traditional	09/25/2025SE
K222299	Steripath Micro Blood Collection SystemJKA · Traditional	11/30/2022SE
K192247	Steripath Gen2 Blood Collection SystemJKA · Traditional	02/28/2020SE

Questions and answers

When was Steripath Micro Blood Collection System cleared by the FDA?

Steripath Micro Blood Collection System (K200661) received a 510(k) decision of Substantially Equivalent on October 8, 2020, 210 days after the submission was received.

What is the product code of K200661?

The FDA product code is FPA – Set, Administration, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 880.5440.