The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Namic Clearacil Contrast Injection Lines.
| Device ID | K163141 |
| 510k Number | K163141 |
| Device Name: | NAMIC ClearaCIL Contrast Injection Lines |
| Classification | Catheter, Intravascular, Diagnostic |
| Applicant | AngioDynamics, Inc. 10 Glens Falls Technology Park Glens Falls, NY 12801 |
| Contact | Teri Juckett |
| Correspondent | Teri Juckett AngioDynamics, Inc. 10 Glens Falls Technology Park Glens Falls, NY 12801 |
| Product Code | DQO |
| CFR Regulation Number | 870.1200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-09 |
| Decision Date | 2017-01-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H965920314831 | K163141 | 000 |
| 20193489069386 | K163141 | 000 |
| 20193489069393 | K163141 | 000 |
| 20193489069409 | K163141 | 000 |
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| H965920313031 | K163141 | 000 |
| H965920314821 | K163141 | 000 |
| H965910314821 | K163141 | 000 |
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| 20193489068778 | K163141 | 000 |