Intravascular IV Set, IV Set with Burette, Extension Set

Q: What is the product code of K001329?

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

FDA 510(k) K001329 · Lifemed of California

Substantially Equivalent

510(k) numberK001329

Submission

Device name: Intravascular IV Set, IV Set with Burette, Extension Set
Applicant: Lifemed of California
Anaheim, CA, US
Received: April 27, 2000
Decision date: February 14, 2001
Decision: Substantially Equivalent (SESE)
Type: Traditional 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.

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K903502	Lifecoil CatheterFJS · Traditional	10/22/1990SE
K841929	Lifemed Lifecoil CathetersFKX · Traditional	08/08/1984SE
K821624	Low Volume Infustion SetFPA · Traditional	06/22/1982SE

Questions and answers

When was Intravascular IV Set, IV Set with Burette, Extension Set cleared by the FDA?

Intravascular IV Set, IV Set with Burette, Extension Set (K001329) received a 510(k) decision of Substantially Equivalent on February 14, 2001, 293 days after the submission was received.

What is the product code of K001329?

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