K870555 is an FDA 510(k) clearance for the VAN-TEC PEDIATRIC SUPRAPUBIC CATHETER SET. This device is classified as a Catheter, Suprapubic (and Accessories) (Class II - Special Controls, product code KOB).
Submitted by Van-Tec, Inc. (Spencer, US). The FDA issued a Cleared decision on March 10, 1987, 28 days after receiving the submission on February 10, 1987.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.5090.
| 510(k) Number | K870555 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 10, 1987 |
| Decision Date | March 10, 1987 |
| Days to Decision | 28 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | KOB — Catheter, Suprapubic (and Accessories) |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.5090 |