K141633 is an FDA 510(k) clearance for the PRO-PICC WITH VALVE 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 Medical Components, Inc. (Harleysville, US). The FDA issued a Cleared decision on September 29, 2014, 103 days after receiving the submission on June 18, 2014.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K141633 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 18, 2014 |
| Decision Date | September 29, 2014 |
| Days to Decision | 103 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 |