K072549 is an FDA 510(k) clearance for the TITANIUM POWERPORT ISP IMPLANTED PORT WITH 6 FR CHRONOFLEX POLYURETHANE CATHETER. This device is classified as a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II - Special Controls, product code LJT).
Submitted by C.R. Bard, Inc. (Salt Lake Ciy,, US). The FDA issued a Cleared decision on November 14, 2007, 65 days after receiving the submission on September 10, 2007.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5965.
| 510(k) Number | K072549 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 10, 2007 |
| Decision Date | November 14, 2007 |
| Days to Decision | 65 days |
| Submission Type | Special |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5965 |