CD Leycom 7 FR Pressure/Volume Catheter (10 MM Electrode Spacing) Pressure/Volume Combination Catheter with Lumen
FDA 510(k) K030524 · Cd Leycom BV
510(k) numberK030524
Submission
- Device name
- CD Leycom 7 FR Pressure/Volume Catheter (10 MM Electrode Spacing) Pressure/Volume Combination Catheter with Lumen
- Applicant
- Cd Leycom BV
Zoetermeer, NL - Received
- February 19, 2003
- Decision date
- March 3, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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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Questions and answers
When was CD Leycom 7 FR Pressure/Volume Catheter (10 MM Electrode Spacing) Pressure/Volume Combination Catheter with Lumen cleared by the FDA?
CD Leycom 7 FR Pressure/Volume Catheter (10 MM Electrode Spacing) Pressure/Volume Combination Catheter with Lumen (K030524) received a 510(k) decision of Substantially Equivalent on March 3, 2003, 12 days after the submission was received.
What is the product code of K030524?
The FDA product code is OBJ – Catheter, Ultrasound, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 870.1200.