The following data is part of a premarket notification filed by Terumo Medical Corp. with the FDA for Coaxial Dual Flow Catheter.
| Device ID | K820859 |
| 510k Number | K820859 |
| Device Name: | COAXIAL DUAL FLOW CATHETER |
| Classification | Set, Dialysis, Single Needle (co-axial Flow) |
| Applicant | TERUMO MEDICAL CORP. 125 BLUE BALL RD. Elkton, MD 21921 |
| Product Code | LBW |
| CFR Regulation Number | 876.5540 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-03-29 |
| Decision Date | 1982-04-16 |