Cleared Abbreviated

K233357 - EsoCool Thermal Regulation Catheter (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K233357 · Nuvaira, Inc. · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Jun 2024
Decision
272d
Days
Class 2
Risk

K233357 is an FDA 510(k) clearance for the EsoCool Thermal Regulation Catheter. Classified as Esophageal Thermal Regulation And Gastric Suctioning Device (product code PLA), Class II - Special Controls.

Submitted by Nuvaira, Inc. (Maple Grove,, US). The FDA issued a Cleared decision on June 27, 2024 after a review of 272 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.5910 - the FDA cardiovascular device oversight framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Nuvaira, Inc. devices

Submission Details

510(k) Number K233357 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 29, 2023
Decision Date June 27, 2024
Days to Decision 272 days
Submission Type Abbreviated
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
147d slower than avg
Panel avg: 125d · This submission: 272d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code PLA Esophageal Thermal Regulation And Gastric Suctioning Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.5910
Definition The Device Is Used To Control A Patient's Temperature, While Simultaneously Maintaining Access To The Stomach To Allow Gastric Decompression And Drainage.
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.