Combomap Pressure and Flow System
FDA 510(k) K041134 · Volcano Therapeutics, Inc.
510(k) numberK041134
Submission
- Device name
- Combomap Pressure and Flow System
- Applicant
- Volcano Therapeutics, Inc.
Rancho Cordova,, CA, US - Received
- April 30, 2004
- Decision date
- June 2, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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Questions and answers
When was Combomap Pressure and Flow System cleared by the FDA?
Combomap Pressure and Flow System (K041134) received a 510(k) decision of Substantially Equivalent on June 2, 2004, 33 days after the submission was received.
What is the product code of K041134?
The FDA product code is OBJ – Catheter, Ultrasound, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 870.1200.