K131687 is an FDA 510(k) clearance for the 6F X 60CM TRIPLE PRO-LINE CT BASIC IR SET. This device is classified as a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II - Special Controls, product code LJS).
Submitted by Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on August 16, 2013, 67 days after receiving the submission on June 10, 2013.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K131687 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 10, 2013 |
| Decision Date | August 16, 2013 |
| Days to Decision | 67 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 |