K971999 is an FDA 510(k) clearance for the PERIPHERALLY INSERTED CENTRAL. 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 November 24, 1997, 178 days after receiving the submission on May 30, 1997.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5970.
| 510(k) Number | K971999 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 30, 1997 |
| Decision Date | November 24, 1997 |
| Days to Decision | 178 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 |