K192211 is an FDA 510(k) clearance for the SoundBite Console, SoundBite Active Wire 18. This device is classified as a Catheter For Crossing Total Occlusions (Class II - Special Controls, product code PDU).
Submitted by Soundbite Medical Solution, Inc. (Montreal, CA). The FDA issued a Cleared decision on January 17, 2020, 156 days after receiving the submission on August 14, 2019.
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 | K192211 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 14, 2019 |
| Decision Date | January 17, 2020 |
| Days to Decision | 156 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. |