K222065 is an FDA 510(k) clearance for the Passeo-35 Xeo Peripheral Dilatation Catheter. This device is classified as a Catheter, Angioplasty, Peripheral, Transluminal (Class II - Special Controls, product code LIT).
Submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on February 16, 2023, 218 days after receiving the submission on July 13, 2022.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1250.
| 510(k) Number | K222065 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 13, 2022 |
| Decision Date | February 16, 2023 |
| Days to Decision | 218 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | LIT — Catheter, Angioplasty, Peripheral, Transluminal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1250 |