JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900— 510(k) K031346
Substantially EquivalentJomed, Inc.
FDA 510(k) clearance K031346 for JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900, Substantially Equivalent on 2003-06-23. Applicant: Jomed, Inc.. Device class: 2.
Clearance details
- Applicant
- Jomed, Inc.
- Product code
- Code OBJ
- Device class
- Class 2
- Regulation
- 21 CFR 870.1200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Rancho Cordova,, CA, US
Recent devices under product code OBJ
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view all- K031148 — IN-VISION IMAGING SYSTEM
- K031277 — JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002
- K022762 — JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050
- K021219 — SMARTWIRE/SMARTMAP PRESSURE SYSTEM
- K003938 — TRAK BACK II
Adverse events under product code OBJ
product code OBJ- Death
- 38
- Injury
- 634
- Malfunction
- 3,453
- Total
- 4,125
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.