Submission Details
| 510(k) Number | K212588 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | August 16, 2021 |
| Decision Date | May 04, 2022 |
| Days to Decision | 261 days |
| Submission Type | Special |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Special
Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty Catheter
May 2022
Decision
261d
Days
Class 2
Risk
About This 510(k) Submission
K212588 is an FDA 510(k) clearance for the Conquest 40 PTA Dilatation Catheter, Atlas Gold PTA Dilatation Catheter, Vida PTV Dilatation Catheter, Vida BAV Balloon Valvuloplasty 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 May 4, 2022, 261 days after receiving the submission on August 16, 2021. 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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