Cleared Traditional

Firefly Needleless Connector

K203796 · Puracath Medical, Inc. · General Hospital
Jul 2021
Decision
214d
Days
Class 2
Risk

About This 510(k) Submission

K203796 is an FDA 510(k) clearance for the Firefly Needleless Connector, a Set, Administration, Intravascular (Class II — Special Controls, product code FPA), submitted by Puracath Medical, Inc. (Newark, US). The FDA issued a Cleared decision on July 30, 2021, 214 days after receiving the submission on December 28, 2020. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5440.

Submission Details

510(k) Number K203796 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 2020
Decision Date July 30, 2021
Days to Decision 214 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FPA — Set, Administration, Intravascular
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5440

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