Submission Details
| 510(k) Number | K132810 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | September 09, 2013 |
| Decision Date | February 28, 2014 |
| Days to Decision | 172 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
GLADIATOR ELITE PTA BALLOON DILATATION CATHETER
Feb 2014
Decision
172d
Days
Class 2
Risk
About This 510(k) Submission
K132810 is an FDA 510(k) clearance for the GLADIATOR ELITE PTA 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 February 28, 2014, 172 days after receiving the submission on September 9, 2013. 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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