K232562 is an FDA 510(k) clearance for the PowerWire Radiofrequency Guidewire Kit. This device is classified as a Catheter For Crossing Total Occlusions (Class II - Special Controls, product code PDU).
Submitted by Baylis Medical Technologies, Inc. (Mississauga, CA). The FDA issued a Cleared decision on February 28, 2024, 188 days after receiving the submission on August 24, 2023.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250. To Facilitate The Intraluminal Placement Of Conventional Guidewires Beyond Stenotic Lesions (including Subchronic And Chronic Total Occlusions) In The Peripheral Vasculature Prior To Further Percutaneous Intervention, Such As Angioplasty, Atherectomy Or Stent Placement..
| 510(k) Number | K232562 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Special 510(k) (SESK) |
| Date Received | August 24, 2023 |
| Decision Date | February 28, 2024 |
| Days to Decision | 188 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | PDU - Catheter For Crossing Total Occlusions |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
| Definition | To Facilitate The Intraluminal Placement Of Conventional Guidewires Beyond Stenotic Lesions (including Subchronic And Chronic Total Occlusions) In The Peripheral Vasculature Prior To Further Percutaneous Intervention, Such As Angioplasty, Atherectomy Or Stent Placement. |