K171931 is an FDA 510(k) clearance for the Celerity ECG Cable Accessory Pack. This device is classified as a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II - Special Controls, product code LJS).
Submitted by Medcomp (Medical Components, Inc.) (Harleysville, US). The FDA issued a Cleared decision on October 26, 2017, 120 days after receiving the submission on June 28, 2017.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K171931 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 28, 2017 |
| Decision Date | October 26, 2017 |
| Days to Decision | 120 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 |