K910486 is an FDA 510(k) clearance for the 8 FR SINGLE LUMEN HIGH PERFORMANCE CATHETER. This device is classified as a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II - Special Controls, product code LJS).
Submitted by Davol, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on April 19, 1991, 72 days after receiving the submission on February 6, 1991.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K910486 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 06, 1991 |
| Decision Date | April 19, 1991 |
| Days to Decision | 72 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | LJS — Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5970 |