K946189 is an FDA 510(k) clearance for the INTROPORT(TM) CATHETER MODEL #1000(ICT). This device is classified as a Port & Catheter, Implanted, Subcutaneous, Intravascular (Class II - Special Controls, product code LJT).
Submitted by Lifequest Medical, Inc. (San Antonio, US). The FDA issued a Cleared decision on July 6, 1995, 198 days after receiving the submission on December 20, 1994.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5965.
| 510(k) Number | K946189 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 20, 1994 |
| Decision Date | July 06, 1995 |
| Days to Decision | 198 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 |