Submission Details
| 510(k) Number | K200410 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | February 19, 2020 |
| Decision Date | May 22, 2020 |
| Days to Decision | 93 days |
| Submission Type | Traditional |
| Review Panel | Cardiovascular (CV) |
| Summary | Summary PDF |
Cleared
Traditional
Reconnaissance PV .018 OTW Digital IVUS Catheter
May 2020
Decision
93d
Days
Class 2
Risk
About This 510(k) Submission
K200410 is an FDA 510(k) clearance for the Reconnaissance PV .018 OTW Digital IVUS Catheter, a Catheter, Ultrasound, Intravascular (Class II — Special Controls, product code OBJ), submitted by Philips Image Guided Therapy Corporation (San Diego, US). The FDA issued a Cleared decision on May 22, 2020, 93 days after receiving the submission on February 19, 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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