The following data is part of a premarket notification filed by Cathera, Inc. with the FDA for Phenom 27 Catheter.
| Device ID | K180959 |
| 510k Number | K180959 |
| Device Name: | Phenom 27 Catheter |
| Classification | Catheter, Percutaneous |
| Applicant | Cathera, Inc. 627 National Ave. Mountain View, CA 94043 |
| Contact | Victor Ham |
| Correspondent | Victor Ham Cathera, Inc. 627 National Ave. Mountain View, CA 94043 |
| Product Code | DQY |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-12 |
| Decision Date | 2018-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00847536041882 | K180959 | 000 |
| 00763000270421 | K180959 | 000 |
| 00763000270391 | K180959 | 000 |
| 00763000270339 | K180959 | 000 |
| 00763000270322 | K180959 | 000 |
| 00763000270315 | K180959 | 000 |
| 00763000270308 | K180959 | 000 |
| 00763000270292 | K180959 | 000 |
| 00763000270254 | K180959 | 000 |
| 00763000270247 | K180959 | 000 |
| 00763000270230 | K180959 | 000 |
| 00763000270223 | K180959 | 000 |
| 00763000270575 | K180959 | 000 |
| 00763000270582 | K180959 | 000 |
| 00763000270599 | K180959 | 000 |
| 00763000270810 | K180959 | 000 |
| 00763000270803 | K180959 | 000 |
| 00763000270797 | K180959 | 000 |
| 00763000270780 | K180959 | 000 |
| 00763000270698 | K180959 | 000 |
| 00763000270681 | K180959 | 000 |
| 00763000270674 | K180959 | 000 |
| 00763000270667 | K180959 | 000 |
| 00763000270650 | K180959 | 000 |
| 00763000270612 | K180959 | 000 |
| 00763000270605 | K180959 | 000 |
| 00763000270216 | K180959 | 000 |