Cleared Special

Finesse Injectable? PTA Balloon Dilatation Catheter

K241740 · Summa Therapeutics · Cardiovascular
Jul 2024
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K241740 is an FDA 510(k) clearance for the Finesse Injectable? PTA Balloon Dilatation Catheter, a Catheter, Angioplasty, Peripheral, Transluminal (Class II — Special Controls, product code LIT), submitted by Summa Therapeutics (Cambridge, US). The FDA issued a Cleared decision on July 16, 2024, 29 days after receiving the submission on June 17, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K241740 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 2024
Decision Date July 16, 2024
Days to Decision 29 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code LIT — Catheter, Angioplasty, Peripheral, Transluminal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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