The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Celerity Picc Tip Confirmation System.
| Device ID | K142889 |
| 510k Number | K142889 |
| Device Name: | Celerity PICC Tip Confirmation System |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | ANGIODYNAMICS, INC. 26 FOREST STREET Marlborough, MA 01751 |
| Contact | Michael Hanley |
| Correspondent | Michael Hanley ANGIODYNAMICS, INC. 26 FOREST STREET Marlborough, MA 01751 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-10-03 |
| Decision Date | 2015-01-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H787471470 | K142889 | 000 |
| H787471460 | K142889 | 000 |
| H787471450 | K142889 | 000 |
| H787471440 | K142889 | 000 |
| H787471430 | K142889 | 000 |
| H787471420 | K142889 | 000 |
| H787471400 | K142889 | 000 |