The following data is part of a premarket notification filed by Boston Scientific Corp. with the FDA for Renegade Hi-flo Microcatheter.
| Device ID | K000177 |
| 510k Number | K000177 |
| Device Name: | RENEGADE HI-FLO MICROCATHETER |
| Classification | Catheter, Continuous Flush |
| Applicant | BOSTON SCIENTIFIC CORP. One Boston Scientific Place Natick, MA 01760 |
| Contact | Terry A Mcgovern |
| Correspondent | Terry A Mcgovern BOSTON SCIENTIFIC CORP. One Boston Scientific Place Natick, MA 01760 |
| Product Code | KRA |
| CFR Regulation Number | 870.1210 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-20 |
| Decision Date | 2000-04-07 |