Submission Details
| 510(k) Number | K203275 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | November 06, 2020 |
| Decision Date | March 01, 2021 |
| Days to Decision | 115 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Recon Support Catheter
Mar 2021
Decision
115d
Days
Class 2
Risk
About This 510(k) Submission
K203275 is an FDA 510(k) clearance for the Recon Support Catheter, a Catheter, Percutaneous (Class II — Special Controls, product code DQY), submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on March 1, 2021, 115 days after receiving the submission on November 6, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1250.
Device Classification
| Product Code | DQY — Catheter, Percutaneous |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1250 |
Manufacturer
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