Submission Details
| 510(k) Number | K210626 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | March 02, 2021 |
| Decision Date | April 23, 2021 |
| Days to Decision | 52 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter
Apr 2021
Decision
52d
Days
Class 2
Risk
About This 510(k) Submission
K210626 is an FDA 510(k) clearance for the SABER .035 Percutaneous Transluminal Angioplasty (PTA) Dilatation Catheter, a Catheter, Angioplasty, Peripheral, Transluminal (Class II — Special Controls, product code LIT), submitted by Cordis Corporation (Miami Lakes, US). The FDA issued a Cleared decision on April 23, 2021, 52 days after receiving the submission on March 2, 2021. 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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