K964066 is an FDA 510(k) clearance for the DUAL SLIM PORT IMPLANTED PORT (0654970/0654940). 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 City, US). The FDA issued a Cleared decision on March 6, 1997, 147 days after receiving the submission on October 10, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5965.
| 510(k) Number | K964066 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 10, 1996 |
| Decision Date | March 06, 1997 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| 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 |