The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for Wavelinq Plus Endoavf System.
| Device ID | K192239 |
| 510k Number | K192239 |
| Device Name: | WavelinQ Plus EndoAVF System |
| Classification | Percutaneous Catheter For Creation Of An Arteriovenous Fistula For Hemodialysis Access |
| Applicant | C.R. Bard, Inc. 1625 West 3rd Street Tempe, AZ 85281 |
| Contact | Kulveen Dhatt |
| Correspondent | Kulveen Dhatt C.R. Bard, Inc. 1625 West 3rd Street Tempe, AZ 85281 |
| Product Code | PQK |
| CFR Regulation Number | 870.1252 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-08-19 |
| Decision Date | 2019-10-17 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00801741189104 | K192239 | 000 |