K992697 is an FDA 510(k) clearance for the PORT-A-CATH II TRANS-ARTERIAL PERCUTANEOUS SYSTEM. This device is classified as a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II - Special Controls, product code LJT).
Submitted by Sims Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on November 18, 1999, 99 days after receiving the submission on August 11, 1999.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5965.
| 510(k) Number | K992697 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | August 11, 1999 |
| Decision Date | November 18, 1999 |
| Days to Decision | 99 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 |