Cleared Special

Stingray LP Catheter

K231176 · Boston Scientific · Cardiovascular
May 2023
Decision
30d
Days
Class 2
Risk

About This 510(k) Submission

K231176 is an FDA 510(k) clearance for the Stingray LP Catheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by Boston Scientific (Maple Grove, US). The FDA issued a Cleared decision on May 25, 2023, 30 days after receiving the submission on April 25, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K231176 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 2023
Decision Date May 25, 2023
Days to Decision 30 days
Submission Type Special
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code DQY — Catheter, Percutaneous
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1250

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