The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Speedlyser Infusion Catheter Kit.
| Device ID | K033443 |
| 510k Number | K033443 |
| Device Name: | SPEEDLYSER INFUSION CATHETER KIT |
| Classification | Catheter, Continuous Flush |
| Applicant | ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury, NY 12804 |
| Contact | Teri Juckett |
| Correspondent | Teri Juckett ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury, NY 12804 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent - Kit With Drugs (SEKD) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2003-10-29 |
| Decision Date | 2003-11-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H787128002045 | K033443 | 000 |
| H787128002025 | K033443 | 000 |
| H787128002015 | K033443 | 000 |