K951524 is an FDA 510(k) clearance for the THORACENTESIS CATHETER. This device is classified as a Catheter And Tip, Suction (Class II - Special Controls, product code JOL).
Submitted by Baxter Healthcare Corp (Mcgaw Park, US). The FDA issued a Cleared decision on July 6, 1995, 94 days after receiving the submission on April 3, 1995.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6740.
| 510(k) Number | K951524 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 03, 1995 |
| Decision Date | July 06, 1995 |
| Days to Decision | 94 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 |