The following data is part of a premarket notification filed by Parke-davis Co. with the FDA for Angio-flo Continuous Arterial Cath Flush Device.
| Device ID | K860570 |
| 510k Number | K860570 |
| Device Name: | ANGIO-FLO CONTINUOUS ARTERIAL CATH FLUSH DEVICE |
| Classification | Catheter, Continuous Flush |
| Applicant | PARKE-DAVIS CO. 870 PARKDALE RD. Rochester, MI 48307 |
| Contact | Cleary |
| Correspondent | Cleary PARKE-DAVIS CO. 870 PARKDALE RD. Rochester, MI 48307 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-02-14 |
| Decision Date | 1986-03-31 |