Submission Details
| 510(k) Number | K870507 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 05, 1987 |
| Decision Date | March 16, 1987 |
| Days to Decision | 39 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | — |
Cleared
Traditional
K870507: GRUNWALD BI-CAVAL & JONES BI-CAVAL CANNULA
Mar 1987
Decision
39d
Days
Class 2
Risk
About This 510(k) Submission
K870507 is an FDA 510(k) clearance for the GRUNWALD BI-CAVAL & JONES BI-CAVAL CANNULA, a Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass (Class II — Special Controls, product code DWF), submitted by Research Medical, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on March 16, 1987, 39 days after receiving the submission on February 5, 1987. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.4210.
Device Classification
| Product Code | DWF — Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.4210 |
Similar Devices — DWF Catheter, Cannula And Tubing, Vascular, Cardiopulmonary Bypass
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