K971085 is an FDA 510(k) clearance for the SOFT TIP MULTI-LUMEN CENTRAL VENOUS CATHETER. This device is classified as a Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (Class II - Special Controls, product code LJS).
Submitted by B.Braun Medical, Inc. (Bethlehem, US). The FDA issued a Cleared decision on June 2, 1997, 69 days after receiving the submission on March 25, 1997.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K971085 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 25, 1997 |
| Decision Date | June 02, 1997 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | LJS — Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5970 |