The following data is part of a premarket notification filed by Calcula Technologies, Inc with the FDA for Peralta Stone Removal Catheter.
| Device ID | K190492 |
| 510k Number | K190492 |
| Device Name: | Peralta Stone Removal Catheter |
| Classification | Dislodger, Stone, Basket, Ureteral, Metal |
| Applicant | Calcula Technologies, Inc 959 Peralta Ave San Francisco, CA 94110 |
| Contact | Raymond Buzz Bonneau |
| Correspondent | Allison Komiyama AcKnowledge Regulatory Strategies, LLC 2251 San Diego Avenue, Suite B-257 San Diego, CA 92110 |
| Product Code | FFL |
| CFR Regulation Number | 876.4680 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-02-28 |
| Decision Date | 2019-07-18 |