K862412 is an FDA 510(k) clearance for the INTESTOPLANT. This device is classified as a Port & Catheter, Implanted, Subcutaneous, Intraperitoneal (Class II - Special Controls, product code LLD).
Submitted by Burron Medical Products, Inc. (Bethlehem, US). The FDA issued a Cleared decision on November 13, 1986, 141 days after receiving the submission on June 25, 1986.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5965.
| 510(k) Number | K862412 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 25, 1986 |
| Decision Date | November 13, 1986 |
| Days to Decision | 141 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | — |
| Product Code | LLD — Port & Catheter, Implanted, Subcutaneous, Intraperitoneal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5965 |