The following data is part of a premarket notification filed by Poiesis Medical, Llc with the FDA for Duette 100% Silicone Dual-balloon, Temperature-sensing Catheter.
| Device ID | K173533 |
| 510k Number | K173533 |
| Device Name: | Duette 100% Silicone Dual-Balloon, Temperature-Sensing Catheter |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | Poiesis Medical, LLC 1095 Jupiter Park Drive Suite 10 Jupiter, FL 33458 |
| Contact | Greg Wiita |
| Correspondent | Grace Powers Powers Regulatory Consulting 2451 Cumberland Parkway SE Suite 3740 Atlanta, GA 30339 |
| Product Code | EZL |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-11-15 |
| Decision Date | 2018-03-29 |
| Summary: | summary |