K220363 is an FDA 510(k) clearance for the VPS Rhythm DLX Device with TipTracker Technology. This device is classified as a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II - Special Controls, product code LJS).
Submitted by Arrow International, LLC (A subsidiary of Teleflex, Inc.) (Morrisville, US). The FDA issued a Cleared decision on August 22, 2022, 195 days after receiving the submission on February 8, 2022.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K220363 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 08, 2022 |
| Decision Date | August 22, 2022 |
| Days to Decision | 195 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LJS — Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5970 |