K961999 is an FDA 510(k) clearance for the SCHNEIDER GUIDER SOFTIP GUIDING CATHETERS. This device is classified as a Catheter, Flow Directed (Class II - Special Controls, product code DYG).
Submitted by Boston Scientific Scimed, Inc. (Plymouth, US). The FDA issued a Cleared decision on November 19, 1996, 181 days after receiving the submission on May 22, 1996.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1240.
| 510(k) Number | K961999 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 22, 1996 |
| Decision Date | November 19, 1996 |
| Days to Decision | 181 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DYG — Catheter, Flow Directed |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1240 |