The following data is part of a premarket notification filed by Potrero Medical, Inc. with the FDA for Accuryn Monitoring System.
| Device ID | K153655 |
| 510k Number | K153655 |
| Device Name: | Accuryn Monitoring System |
| Classification | Catheter, Retention Type, Balloon |
| Applicant | POTRERO MEDICAL, INC. 101 MISSISSIPPI ST. San Francisco, CA 94107 |
| Contact | Devyani Nanduri |
| Correspondent | Devyani Nanduri POTRERO MEDICAL, INC. 101 MISSISSIPPI ST. San Francisco, CA 94107 |
| Product Code | EZL |
| Subsequent Product Code | EXY |
| Subsequent Product Code | PHU |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-21 |
| Decision Date | 2016-04-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00868475000235 | K153655 | 000 |
| 00850019755206 | K153655 | 000 |
| 00850019755213 | K153655 | 000 |
| 00850019755220 | K153655 | 000 |
| 00850019755237 | K153655 | 000 |
| 00850019755244 | K153655 | 000 |
| 00850019755251 | K153655 | 000 |
| 10850019755128 | K153655 | 000 |
| 10888277688483 | K153655 | 000 |
| 00868475000273 | K153655 | 000 |
| 00868475000297 | K153655 | 000 |
| 00850019755008 | K153655 | 000 |