FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002
K Number: K031277
·
Decision May 14, 2003
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
6
Review Days
22
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Basic Information
- Device Name
- JOWIRE ASAHI PTCA CATHETER GUIDE WIRES, MODELS AG145300,141300,142300,132200,14M350,14M345,14M360,143390,141002
- K Number
- K031277
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Jomed, Inc.
- Date Received
- April 22, 2003
- Decision Date
- May 14, 2003
- Product Code
- DQX
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| DQX | Wire, Guide, Catheter | FDA class 2 | Cardiovascular |
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Other Clearances by Jomed, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K031346 | JOVUS EAGLE EYE F/X 2.9F IVUS CATHETER, MODEL 85900 | Jun 23, 2003 | Substantially Equivalent |
| K031148 | IN-VISION IMAGING SYSTEM | May 28, 2003 | Substantially Equivalent |
| K022762 | JOWIRE NEO'S PTCA CATHETER GUIDEWIRES, MODELS AG141000, AG142000, AG143000, AG141002, AG141010, AG14M060 & AG14M050 | Dec 16, 2002 | Substantially Equivalent |
| K021219 | SMARTWIRE/SMARTMAP PRESSURE SYSTEM | May 17, 2002 | Substantially Equivalent |
| K003938 | TRAK BACK II | Jan 18, 2001 | Substantially Equivalent |