The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Percutaneous Catheter Infusion System.
| Device ID | K953384 |
| 510k Number | K953384 |
| Device Name: | PERCUTANEOUS CATHETER INFUSION SYSTEM |
| Classification | Catheter, Continuous Flush |
| Applicant | ANGIODYNAMICS, INC. P.O. BOX 993 266 QUEENSBURY AVENUE Glens Falls, NY 12801 |
| Contact | Brian Kunst |
| Correspondent | Brian Kunst ANGIODYNAMICS, INC. P.O. BOX 993 266 QUEENSBURY AVENUE Glens Falls, NY 12801 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-19 |
| Decision Date | 1995-12-22 |