HydroMID
Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Access Vascular Inc.
The following data is part of a premarket notification filed by Access Vascular Inc. with the FDA for Hydromid.
Pre-market Notification Details
| Device ID | K203069 |
| 510k Number | K203069 |
| Device Name: | HydroMID |
| Classification | Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days |
| Applicant | Access Vascular Inc. 175 Middlesex Turnpike Suite 1A Bedford, MA 01730 |
| Contact | Brian Hanley |
| Correspondent | Brian Hanley Access Vascular Inc. 175 Middlesex Turnpike Suite 1A Bedford, MA 01730 |
| Product Code | FOZ |
| CFR Regulation Number | 880.5200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-10-09 |
| Decision Date | 2021-02-08 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00862559000449 | K203069 | 000 |
| 00850030354020 | K203069 | 000 |
| 00850030354013 | K203069 | 000 |
| 00850030354006 | K203069 | 000 |
Trademark Results [HydroMID]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 HYDROMID 90229032 not registered Live/Pending |
Access Vascular, Inc. 2020-10-01 |
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