Cleared Traditional

Teleport XT Microcatheter (K231608) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

K231608 is an FDA 510(k) clearance for the Teleport XT Microcatheter. Classified as Catheter, Percutaneous (product code DQY), Class II - Special Controls.

Submitted by OrbusNeich Medical (Shenzhen) Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on January 7, 2024 after a review of 219 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1250 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all OrbusNeich Medical (Shenzhen) Co., Ltd. devices

Submission Details

510(k) Number K231608 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
94d slower than avg
Panel avg: 125d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQY Catheter, Percutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1250
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - DQY Catheter, Percutaneous

All 316
Devices cleared under the same product code (DQY) and FDA review panel - the closest regulatory comparables to K231608.
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