The following data is part of a premarket notification filed by Phenox Limited with the FDA for Portal Steerable Hydrophilic Guidewire And Portal Ext Extension Wire.
| Device ID | K191687 |
| 510k Number | K191687 |
| Device Name: | PORTAL Steerable Hydrophilic Guidewire And PORTAL EXT Extension Wire |
| Classification | Wire, Guide, Catheter |
| Applicant | phenox Limited Kamrick Court, Ballybrit Business Park Galway, IE H91xy38 |
| Contact | Gary Brogan |
| Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2019-06-24 |
| Decision Date | 2019-10-09 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05391530910057 | K191687 | 000 |
| 05391530910040 | K191687 | 000 |