Submission Details
| 510(k) Number | K141150 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 05, 2014 |
| Decision Date | September 25, 2014 |
| Days to Decision | 143 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
PTA BALLOON DILATATION CATHETER
Sep 2014
Decision
143d
Days
Class 2
Risk
About This 510(k) Submission
K141150 is an FDA 510(k) clearance for the 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 September 25, 2014, 143 days after receiving the submission on May 5, 2014. 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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