Flowpicc Console
FDA 510(k) K081626 · Vasonova, Inc.
510(k) numberK081626
Submission
- Device name
- Flowpicc Console
- Applicant
- Vasonova, Inc.
Sunnyvale, CA, US - Received
- June 10, 2008
- Decision date
- October 15, 2008
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OBJ – Catheter, Ultrasound, Intravascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1200
- Specialty
- Cardiovascular
For intracardiac and intraluminal visualization of cardiovascular anatomy and physiology.
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More from Philips Image Guided Therapy Corporation
| 510(k) | Device | Decision |
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| K123813 | Vascular Positioning System (VPS) G4 ConsoleOBJ · Special | 01/18/2013SE |
| K103260 | Vascular Positioning System (VPS System) ConsoleOBJ · Traditional | 02/18/2011SE |
| K103255 | Vascular Positioning System TM (VPS TM System) StyletOBJ · Traditional | 02/18/2011SE |
| K091924 | VPS CatheterLJS · Traditional | 11/18/2009SE |
| K083920 | Flowpicc CatheterLJS · Traditional | 05/01/2009SE |
| K082481 | Flowpicc CatheterLJS · Traditional | 12/17/2008SE |
| K081625 | Flowpicc StyletOBJ · Traditional | 09/26/2008SE |
Questions and answers
When was Flowpicc Console cleared by the FDA?
Flowpicc Console (K081626) received a 510(k) decision of Substantially Equivalent on October 15, 2008, 127 days after the submission was received.
What is the product code of K081626?
The FDA product code is OBJ – Catheter, Ultrasound, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 870.1200.