K252527 is an FDA 510(k) clearance for the Surfacer Inside-Out Access Catheter System. This device is classified as a Reverse Central Venous Recanalization System (Class II - Special Controls, product code QJH).
Submitted by Merit Medical System, Inc. (South Jordan, US). The FDA issued a Cleared decision on September 10, 2025, 30 days after receiving the submission on August 11, 2025.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1342. A Reverse Central Venous Recanalization System Is A Prescription Device Intended For Obtaining Central Venous Access To Facilitate Catheter Insertion Into The Central Venous System. Reverse Recanalization Involves The Initiation Of An Access Path From Within The Vein And Then Progressing To The Skin For Patients With Upper Body Venous Occlusions Or Other Conditions That Preclude Central Venous Access By Other Methods..
| 510(k) Number | K252527 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Abbreviated 510(k) (SESU) |
| Date Received | August 11, 2025 |
| Decision Date | September 10, 2025 |
| Days to Decision | 30 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | QJH - Reverse Central Venous Recanalization System |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1342 |
| Definition | A Reverse Central Venous Recanalization System Is A Prescription Device Intended For Obtaining Central Venous Access To Facilitate Catheter Insertion Into The Central Venous System. Reverse Recanalization Involves The Initiation Of An Access Path From Within The Vein And Then Progressing To The Skin For Patients With Upper Body Venous Occlusions Or Other Conditions That Preclude Central Venous Access By Other Methods. |