The following data is part of a premarket notification filed by Access Vascular, Inc. with the FDA for Hydromid 4f Single Lumen Midline Catheter.
| Device ID | K220772 |
| 510k Number | K220772 |
| Device Name: | HydroMID 4F Single Lumen Midline Catheter |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | Access Vascular, Inc. 749 Middlesex Turnpike Billirica, MA 01821 |
| Contact | Brian M. Hanley |
| Correspondent | Brian M. Hanley Access Vascular, Inc. 749 Middlesex Turnpike Billerica, MA 01821 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-16 |
| Decision Date | 2022-12-07 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00850030354365 | K220772 | 000 |
| 00850030354358 | K220772 | 000 |
| 00850030354341 | K220772 | 000 |
| 00850030354211 | K220772 | 000 |
| 00850030354204 | K220772 | 000 |