Submission Details
| 510(k) Number | K191469 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 03, 2019 |
| Decision Date | August 01, 2019 |
| Days to Decision | 59 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Biotronik Stylets
Aug 2019
Decision
59d
Days
Class 2
Risk
About This 510(k) Submission
K191469 is an FDA 510(k) clearance for the Biotronik Stylets, a Stylet, Catheter (Class II — Special Controls, product code DRB), submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on August 1, 2019, 59 days after receiving the submission on June 3, 2019. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1380.
Device Classification
| Product Code | DRB — Stylet, Catheter |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1380 |
Manufacturer
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