The following data is part of a premarket notification filed by Nipro Medical Corporation with the FDA for Cronus Hp - High Pressure Peripheral Balloon Catheter.
| Device ID | K151141 |
| 510k Number | K151141 |
| Device Name: | Cronus HP - High Pressure Peripheral Balloon Catheter |
| Classification | Catheter, Angioplasty, Peripheral, Transluminal |
| Applicant | NIPRO MEDICAL CORPORATION 3150 NW 107TH AVE. Doral, FL 33172 |
| Contact | Jessica Oswald-mcleod |
| Correspondent | Jessica Oswald-mcleod 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 | 2015-04-29 |
| Decision Date | 2016-01-14 |
| Summary: | summary |