K153434 is an FDA 510(k) clearance for the Pall-Aquasafe Water Filter. This device is classified as a System, Water Purification, General Medical Use (Class II - Special Controls, product code NHV).
Submitted by Pall International Sarl (Fribourg, CH). The FDA issued a Cleared decision on June 10, 2016, 196 days after receiving the submission on November 27, 2015.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5665. The Device Is A Portable Water Treatment System Which Features Components And Technology Similar To Water Treatment Systems Previously Cleared For Hemodialysis. The Difference Lies With The Intended Use, As The Proposed Device Is Not Intended For Use In Hemodialysis Applications, For Which A Product Code Currently Exists. Instead, The Proposed Device Is Intended For Use To Purify Water For General Purposes, Including Washing Of Surgeons Hands, Surgical Instruments, And Wound Cleansing..
| 510(k) Number | K153434 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 27, 2015 |
| Decision Date | June 10, 2016 |
| Days to Decision | 196 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | Summary PDF |
| Product Code | NHV — System, Water Purification, General Medical Use |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5665 |
| Definition | The Device Is A Portable Water Treatment System Which Features Components And Technology Similar To Water Treatment Systems Previously Cleared For Hemodialysis. The Difference Lies With The Intended Use, As The Proposed Device Is Not Intended For Use In Hemodialysis Applications, For Which A Product Code Currently Exists. Instead, The Proposed Device Is Intended For Use To Purify Water For General Purposes, Including Washing Of Surgeons Hands, Surgical Instruments, And Wound Cleansing. |