SMARTWIRE/SMARTMAP PRESSURE SYSTEM— 510(k) K021219
Substantially EquivalentJomed, Inc.
FDA 510(k) clearance K021219 for SMARTWIRE/SMARTMAP PRESSURE SYSTEM, Substantially Equivalent on 2002-05-17. Applicant: Jomed, Inc.. Device class: 2.
Clearance details
- Applicant
- Jomed, Inc.
- Product code
- Code DQX
- Device class
- Class 2
- Regulation
- 21 CFR 870.1330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Rancho Cordova,, CA, US
Recent devices under product code DQX
view allMore clearances from Jomed, Inc.
view all- K031346 — JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900
- 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
- K003938 — TRAK BACK II
Adverse events under product code DQX
product code DQX- Death
- 298
- Injury
- 4,385
- Malfunction
- 7,203
- Other
- 5
- Total
- 11,891
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.