Submission Details
| 510(k) Number | K150303 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 06, 2015 |
| Decision Date | June 15, 2015 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
XXL Vascular Balloon Dilatation Catheter
Jun 2015
Decision
129d
Days
Class 2
Risk
About This 510(k) Submission
K150303 is an FDA 510(k) clearance for the XXL Vascular Balloon Dilatation Catheter, a Catheter, Angioplasty, Peripheral, Transluminal (Class II — Special Controls, product code LIT), submitted by Boston Scientific Corp (Maple Grove, US). The FDA issued a Cleared decision on June 15, 2015, 129 days after receiving the submission on February 6, 2015. 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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