Submission Details
| 510(k) Number | K200195 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | January 27, 2020 |
| Decision Date | June 22, 2020 |
| Days to Decision | 147 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
NES Reprocessed Visions PV .014P RX Digital IVUS Catheter
Jun 2020
Decision
147d
Days
Class 2
Risk
About This 510(k) Submission
K200195 is an FDA 510(k) clearance for the NES Reprocessed Visions PV .014P RX Digital IVUS Catheter, a Catheter, Ultrasound, Intravascular (Class II — Special Controls, product code OBJ), submitted by Northeast Scientific, Inc. (Waterbury, US). The FDA issued a Cleared decision on June 22, 2020, 147 days after receiving the submission on January 27, 2020. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1200.
Device Classification
| Product Code | OBJ — Catheter, Ultrasound, Intravascular |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 870.1200 |
| Definition | For Intracardiac And Intraluminal Visualization Of Cardiovascular Anatomy And Physiology. |
Manufacturer
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