The following data is part of a premarket notification filed by Bard Peripheral Vascular, Inc. with the FDA for Sidekick And Usher Support Catheters.
| Device ID | K161986 |
| 510k Number | K161986 |
| Device Name: | SIDEKICK And USHER Support Catheters |
| Classification | Catheter, Percutaneous |
| Applicant | BARD PERIPHERAL VASCULAR, INC. 1625 WEST 3RD STREET Tempe, AZ 85281 |
| Contact | Melanie Hadlock |
| Correspondent | Melanie Hadlock BARD PERIPHERAL VASCULAR, INC. 1625 WEST 3RD STREET Tempe, AZ 85281 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-07-19 |
| Decision Date | 2016-08-04 |
| Summary: | summary |