Submission Details
| 510(k) Number | K123358 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | October 31, 2012 |
| Decision Date | January 29, 2013 |
| Days to Decision | 90 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
PACIFIC PLUS
Jan 2013
Decision
90d
Days
Class 2
Risk
About This 510(k) Submission
K123358 is an FDA 510(k) clearance for the PACIFIC PLUS, a Catheter, Angioplasty, Peripheral, Transluminal (Class II — Special Controls, product code LIT), submitted by Medtronic Vascular (Santa Rosa, US). The FDA issued a Cleared decision on January 29, 2013, 90 days after receiving the submission on October 31, 2012. 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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