Submission Details
| 510(k) Number | K223177 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 11, 2022 |
| Decision Date | January 20, 2023 |
| Days to Decision | 101 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Highlander? 014 PTA Balloon Dilatation Catheter
Jan 2023
Decision
101d
Days
Class 2
Risk
About This 510(k) Submission
K223177 is an FDA 510(k) clearance for the Highlander? 014 PTA Balloon Dilatation Catheter, a Catheter, Angioplasty, Peripheral, Transluminal (Class II — Special Controls, product code LIT), submitted by C.R. Bard, Inc. (Tempe, US). The FDA issued a Cleared decision on January 20, 2023, 101 days after receiving the submission on October 11, 2022. 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 |
Manufacturer
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