HIgH-Flo Super26 Subcutaneous Needle Sets

Q: What is the product code of K180843?

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

FDA 510(k) K180843 · Repro-Med Systems, Inc. Dba Rms Medical Products

Substantially Equivalent

510(k) numberK180843

Submission

Device name: HIgH-Flo Super26 Subcutaneous Needle Sets
Applicant: Repro-Med Systems, Inc. Dba Rms Medical Products
New York, NY, US
Received: April 2, 2018
Decision date: April 4, 2019
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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Questions and answers

When was HIgH-Flo Super26 Subcutaneous Needle Sets cleared by the FDA?

HIgH-Flo Super26 Subcutaneous Needle Sets (K180843) received a 510(k) decision of Substantially Equivalent on April 4, 2019, 367 days after the submission was received.

What is the product code of K180843?

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