K960312 is an FDA 510(k) clearance for the RDI CARDIAC INSULATION PAD. This device is classified as a Dilator, Vessel, Surgical (Class II - Special Controls, product code DWP).
Submitted by R D Intl. (Richardson, US). The FDA issued a Cleared decision on April 19, 1996, 88 days after receiving the submission on January 22, 1996.
This device falls under the Cardiovascular FDA review panel. Regulated under 21 CFR 870.4475.
| 510(k) Number | K960312 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 22, 1996 |
| Decision Date | April 19, 1996 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
| Product Code | DWP — Dilator, Vessel, Surgical |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 870.4475 |