K912702 is an FDA 510(k) clearance for the PLASTIC ATTACHABLE DUAL PORT. This device is classified as a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II - Special Controls, product code LJT).
Submitted by Davol, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on September 18, 1991, 91 days after receiving the submission on June 19, 1991.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5965.
| 510(k) Number | K912702 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 19, 1991 |
| Decision Date | September 18, 1991 |
| Days to Decision | 91 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Statement |
| Product Code | LJT — Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5965 |