inforMED
PLAClass II

Esophageal Thermal Regulation And Gastric Suctioning Device

Cardiovascular · 21 CFR 870.5910

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

MDR events16All time
Recalls0All time
Registered firms6Currently listed
510(k) clearances9All time

Recent MDR events

16 adverse event reports on file

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Event type breakdown

Injury11
Malfunction4
Death1

Most-reported manufacturers

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Advanced Cooling Therapy Inc. D/b/a Attune Medical9Advanced Cooling Therapy1Advanced Cooling Therapy, Inc.1Advanced Cooling Therapy, Inc. D/b/a Attune Medica1Attune Medical1Attune Medical / Advanced Cooling Therapy, Inc.1Gaymar Industries, Inc.1Stryker Corporation1

Recalls

0 recall events for this product code

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No recalls on file for this product code.

Registered firms

6 firms currently registered for this product code

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510(k) clearances

9 clearances for this product code

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