The following data is part of a premarket notification filed by Angiodynamics, Inc. with the FDA for Angiodynamics, Inc., Smart Port Ct Series Port Access Systems.
| Device ID | K101017 |
| 510k Number | K101017 |
| Device Name: | ANGIODYNAMICS, INC., SMART PORT CT SERIES PORT ACCESS SYSTEMS |
| Classification | Port & Catheter, Implanted, Subcutaneous, Intravascular |
| Applicant | ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury, NY 12804 |
| Contact | S. Michael Sharp |
| Correspondent | S. Michael Sharp ANGIODYNAMICS, INC. 603 QUEENSBURY AVE. Queensbury, NY 12804 |
| Product Code | LJT |
| CFR Regulation Number | 880.5965 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-04-12 |
| Decision Date | 2010-06-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| H787CT66PTPDVI1 | K101017 | 000 |
| H787CT66PTPDNF0 | K101017 | 000 |
| H787CT66PTPD0 | K101017 | 000 |
| H787CT66LTPDVI1 | K101017 | 000 |
| H787CT66LTPDNF0 | K101017 | 000 |
| H787CT66LTPD0 | K101017 | 000 |