K974397 is an FDA 510(k) clearance for the STERILE SALINE FOR CATHETER CARE. This device is classified as a Catheter And Tip, Suction (Class II - Special Controls, product code JOL).
Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on February 10, 1998, 81 days after receiving the submission on November 21, 1997.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K974397 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | November 21, 1997 |
| Decision Date | February 10, 1998 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | JOL — Catheter And Tip, Suction |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.6740 |