The following data is part of a premarket notification filed by Brivant Limited with the FDA for Hydraview Guidewire.
| Device ID | K141831 |
| 510k Number | K141831 |
| Device Name: | HYDRAVIEW GUIDEWIRE |
| Classification | Wire, Guide, Catheter |
| Applicant | BRIVANT LIMITED PARKMORE WEST BUSINESS PARK Galway, IE |
| Contact | Kenneth Walsh |
| Correspondent | Kenneth Walsh BRIVANT LIMITED PARKMORE WEST BUSINESS PARK Galway, IE |
| Product Code | DQX |
| CFR Regulation Number | 870.1330 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-07-07 |
| Decision Date | 2014-09-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00685447005599 | K141831 | 000 |
| 00685447005582 | K141831 | 000 |
| 00685447005575 | K141831 | 000 |
| 00685447005568 | K141831 | 000 |
| 00685447005551 | K141831 | 000 |
| 00685447005544 | K141831 | 000 |