Submission Details
| 510(k) Number | K190037 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 08, 2019 |
| Decision Date | October 24, 2019 |
| Days to Decision | 289 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
K190037 - Cronus HP PTA Balloon Catheter
(FDA 510(k) Clearance)
Oct 2019
Decision
289d
Days
Class 2
Risk
K190037 is an FDA 510(k) clearance for the Cronus HP PTA Balloon Catheter, a Catheter, Angioplasty, Peripheral, Transluminal (Class II — Special Controls, product code LIT), submitted by Nipro Medical Corporation (Doral, US). The FDA issued a Cleared decision on October 24, 2019, 289 days after receiving the submission on January 8, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.
Device Classification
| Product Code | LIT — Catheter, Angioplasty, Peripheral, Transluminal |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
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