Jovus Eagle Eye F/X 2.9F Ivus Catheter, Model 85900
FDA 510(k) K031346 · Jomed, Inc.
510(k) numberK031346
Submission
- Device name
- Jovus Eagle Eye F/X 2.9F Ivus Catheter, Model 85900
- Applicant
- Jomed, Inc.
Rancho Cordova,, CA, US - Received
- April 29, 2003
- Decision date
- June 23, 2003
- 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 Jovus Eagle Eye F/X 2.9F Ivus Catheter, Model 85900 cleared by the FDA?
Jovus Eagle Eye F/X 2.9F Ivus Catheter, Model 85900 (K031346) received a 510(k) decision of Substantially Equivalent on June 23, 2003, 55 days after the submission was received.
What is the product code of K031346?
The FDA product code is OBJ – Catheter, Ultrasound, Intravascular, a Class II (moderate risk) device regulated under 21 CFR 870.1200.