Cleared Traditional

Nouvo Safety Set

K232234 · Poly Medicure Limited · General Hospital
Mar 2024
Decision
232d
Days
Class 2
Risk

About This 510(k) Submission

K232234 is an FDA 510(k) clearance for the Nouvo Safety Set, a Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (Class II — Special Controls, product code FOZ), submitted by Poly Medicure Limited (Faridabad, IN). The FDA issued a Cleared decision on March 15, 2024, 232 days after receiving the submission on July 27, 2023. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5200.

Submission Details

510(k) Number K232234 FDA.gov
FDA Decision Cleared SESE
Date Received July 27, 2023
Decision Date March 15, 2024
Days to Decision 232 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF

Device Classification

Product Code FOZ — Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class II — Special Controls
CFR Regulation 21 CFR 880.5200

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