The following data is part of a premarket notification filed by Revascular Therapeutics, Inc. with the FDA for Rvt Cto Device.
| Device ID | K101599 |
| 510k Number | K101599 |
| Device Name: | RVT CTO DEVICE |
| Classification | Catheter For Crossing Total Occlusions |
| Applicant | REVASCULAR THERAPEUTICS, INC. 766 PALOMAR AVENUE Sunnyvale, CA 94085 |
| Contact | Nancy Lince |
| Correspondent | Nancy Lince REVASCULAR THERAPEUTICS, INC. 766 PALOMAR AVENUE Sunnyvale, CA 94085 |
| Product Code | PDU |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-06-07 |
| Decision Date | 2011-01-18 |
| Summary: | summary |