Cleared Traditional

Teleport XT Microcatheter

K231608 · OrbusNeich Medical (Shenzhen) Co., Ltd. · Cardiovascular
Jan 2024
Decision
219d
Days
Class 2
Risk

About This 510(k) Submission

K231608 is an FDA 510(k) clearance for the Teleport XT Microcatheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by OrbusNeich Medical (Shenzhen) Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 7, 2024, 219 days after receiving the submission on June 2, 2023. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.

Submission Details

510(k) Number K231608 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2023
Decision Date January 07, 2024
Days to Decision 219 days
Submission Type Traditional
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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