510(k) K200410
K200410 is an FDA 510(k) premarket notification submitted by Philips Image Guided Therapy Corporation for the device "Reconnaissance PV .018 OTW Digital IVUS Catheter". The FDA issued a decision of Substantially Equivalent on May 22, 2020. The device falls under product code OBJ (Catheter, Ultrasound, Intravascular), a Class II device regulated under 21 CFR 870.1200. Philips Image Guided Therapy Corporation has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 22, 2020
- Date Received
- February 19, 2020
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Catheter, Ultrasound, Intravascular
- Device Class
- Class II
- Regulation Number
- 870.1200
- Review Panel
- CV
- Submission Type
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.