K870734 is an FDA 510(k) clearance for the TEFLON BIOPSY CATHETER W/TIP ANGLE. This device is classified as a Instrument, Biopsy (Class II - Special Controls, product code KNW).
Submitted by Van-Tec, Inc. (Spencer, US). The FDA issued a Cleared decision on March 10, 1987, 13 days after receiving the submission on February 25, 1987.
This device falls under the Gastroenterology & Urology FDA review panel. Regulated under 21 CFR 876.1075.
| 510(k) Number | K870734 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 25, 1987 |
| Decision Date | March 10, 1987 |
| Days to Decision | 13 days |
| Submission Type | Traditional |
| Review Panel | Gastroenterology & Urology (GU) |
| Summary | — |
| Product Code | KNW — Instrument, Biopsy |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 876.1075 |