The following data is part of a premarket notification filed by Nipro Medical Corporation with the FDA for Cronus Hp Pta Balloon Catheter.
| Device ID | K190037 |
| 510k Number | K190037 |
| Device Name: | Cronus HP PTA Balloon Catheter |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | Nipro Medical Corporation 3150 NW 107th Ave. Doral, FL 33172 |
| Contact | Jessica Oswald-mcleon |
| Correspondent | Jessica Oswald-mcleon Nipro Medical Corporation 3150 NW 107th Ave. Doral, FL 33172 |
| Product Code | LIT |
| CFR Regulation Number | 870.1250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-08 |
| Decision Date | 2019-10-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00383790009591 | K190037 | 000 |
| 00383790009515 | K190037 | 000 |
| 00383790009430 | K190037 | 000 |
| 00383790009416 | K190037 | 000 |
| 00383790009331 | K190037 | 000 |
| 00383790009317 | K190037 | 000 |
| 00383790009294 | K190037 | 000 |
| 00383790009270 | K190037 | 000 |
| 00383790009256 | K190037 | 000 |
| 00383790009232 | K190037 | 000 |
| 00383790009218 | K190037 | 000 |
| 00383790009195 | K190037 | 000 |
| 00383790009171 | K190037 | 000 |
| 00383790009157 | K190037 | 000 |
| 00383790009133 | K190037 | 000 |
| 00383790009539 | K190037 | 000 |
| 00383790009720 | K190037 | 000 |
| 00383790009744 | K190037 | 000 |
| 00383790009577 | K190037 | 000 |
| 00383790009553 | K190037 | 000 |
| 00383790009492 | K190037 | 000 |
| 00383790009478 | K190037 | 000 |
| 00383790009454 | K190037 | 000 |
| 00383790009393 | K190037 | 000 |
| 00383790009379 | K190037 | 000 |
| 00383790009355 | K190037 | 000 |
| 00383790009867 | K190037 | 000 |
| 00383790009843 | K190037 | 000 |
| 00383790009829 | K190037 | 000 |
| 00383790009805 | K190037 | 000 |
| 00383790009782 | K190037 | 000 |
| 00383790009768 | K190037 | 000 |
| 00383790009119 | K190037 | 000 |