The following data is part of a premarket notification filed by Peripheral Systems Group with the FDA for Edm(r) Infusion Catheter.
| Device ID | K914979 |
| 510k Number | K914979 |
| Device Name: | EDM(R) INFUSION CATHETER |
| Classification | Catheter, Continuous Flush |
| Applicant | PERIPHERAL SYSTEMS GROUP 1395 CHARLESTON RD. Mountain View, CA 94043 |
| Contact | Jessica Ayres |
| Correspondent | Jessica Ayres PERIPHERAL SYSTEMS GROUP 1395 CHARLESTON RD. Mountain View, CA 94043 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-11-06 |
| Decision Date | 1992-09-16 |