Submission Details
| 510(k) Number | K201445 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 01, 2020 |
| Decision Date | September 02, 2021 |
| Days to Decision | 458 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
MultiCath, AcQRate Dx Fixed Curve Catheter
Sep 2021
Decision
458d
Days
Class 2
Risk
About This 510(k) Submission
K201445 is an FDA 510(k) clearance for the MultiCath, AcQRate Dx Fixed Curve Catheter, a Catheter, Electrode Recording, Or Probe, Electrode Recording (Class II — Special Controls, product code DRF), submitted by Biotronik, Inc. (Lake Oswego, US). The FDA issued a Cleared decision on September 2, 2021, 458 days after receiving the submission on June 1, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1220.
Device Classification
| Product Code | DRF — Catheter, Electrode Recording, Or Probe, Electrode Recording |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1220 |
Manufacturer
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