The following data is part of a premarket notification filed by Access Vascular Inc with the FDA for Hydropicc 5f Dual Lumen Catheter.
| Device ID | K213550 |
| 510k Number | K213550 |
| Device Name: | HydroPICC 5F Dual Lumen Catheter |
| Classification | Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days |
| Applicant | Access Vascular Inc 175 Middlesex Trunpike Bedford, MA 01730 |
| Contact | Brian Hanley |
| Correspondent | Brian Hanley Access Vascular Inc 175 Middlesex Trunpike Bedford, MA 01730 |
| Product Code | LJS |
| CFR Regulation Number | 880.5970 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-11-08 |
| Decision Date | 2022-05-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850030354068 | K213550 | 000 |
| 00850030354327 | K213550 | 000 |
| 00850030354334 | K213550 | 000 |
| 00850030354389 | K213550 | 000 |
| 00850030354259 | K213550 | 000 |
| 00850030354266 | K213550 | 000 |
| 00850030354273 | K213550 | 000 |
| 00850030354037 | K213550 | 000 |
| 00850030354044 | K213550 | 000 |
| 00850030354310 | K213550 | 000 |