510(k) K170009
K170009 is an FDA 510(k) premarket notification submitted by Advanced Cooling Therapy, LLC for the device "Esophageal Cooling Device". The FDA issued a decision of Substantially Equivalent on Mar 30, 2017. The device falls under product code PLA (Esophageal Thermal Regulation And Gastric Suctioning Device), a Class II device regulated under 21 CFR 870.5910. Advanced Cooling Therapy, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 30, 2017
- Date Received
- Jan 3, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Esophageal Thermal Regulation And Gastric Suctioning Device
- Device Class
- Class II
- Regulation Number
- 870.5910
- Review Panel
- CV
- Submission Type
The device is used to control a patient's temperature, while simultaneously maintaining access to the stomach to allow gastric decompression and drainage.