The following data is part of a premarket notification filed by Advanced Interventional Technologies, Llc with the FDA for Magic Infusion Catheter.
| Device ID | K023351 |
| 510k Number | K023351 |
| Device Name: | MAGIC INFUSION CATHETER |
| Classification | Catheter, Continuous Flush |
| Applicant | ADVANCED INTERVENTIONAL TECHNOLOGIES, LLC 100 MAIN ST. SUITE 120 Concord, MA 01742 |
| Contact | Tracy Palmer Berns |
| Correspondent | Tracy Palmer Berns ADVANCED INTERVENTIONAL TECHNOLOGIES, LLC 100 MAIN ST. SUITE 120 Concord, MA 01742 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-07 |
| Decision Date | 2003-02-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00818053022838 | K023351 | 000 |
| 00818053022821 | K023351 | 000 |
| 00818053022647 | K023351 | 000 |
| 00818053022630 | K023351 | 000 |
| 00818053022623 | K023351 | 000 |
| 00818053022616 | K023351 | 000 |
| 00818053022609 | K023351 | 000 |
| 00818053022593 | K023351 | 000 |
| 00818053022586 | K023351 | 000 |