Esophageal Thermal Regulation And Gastric Suctioning Device

PLA · Class II — Moderate Risk (510(k) clearance required) · Cardiovascular · 21 CFR 870.5910

Classification

FDA Product Code: PLA
Device class: Class II — Moderate Risk (510(k) clearance required)
Regulation: 21 CFR 870.5910
Review panel: CV
Medical specialty: Cardiovascular
Submission type: 1
GMP exempt: N
Life sustaining: N
Implant: N
Third-party review: Y

Definition

The device is used to control a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage.

Market data

Cleared 510(k) submissions: 9
Registered establishments: 2

Source

Authoritative: FDA Device Classification database
Machine: JSON-LD · Markdown