K963988 is an FDA 510(k) clearance for the INTRAVASCULAR INFUSION DEVICE. This device is classified as a Catheter, Continuous Flush (Class II - Special Controls, product code KRA).
Submitted by Boston Scientific Corp (Natick,, US). The FDA issued a Cleared decision on December 12, 1996, 69 days after receiving the submission on October 4, 1996.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.1210.
| 510(k) Number | K963988 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 04, 1996 |
| Decision Date | December 12, 1996 |
| Days to Decision | 69 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | KRA — Catheter, Continuous Flush |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.1210 |