FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇪 Ireland
3 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG TAPER .014) SHORT TAPER, 2 PIECE PARODI GUIDEWIRE SYSTEM (LON
K Number: K093515
·
Decision Feb 16, 2010
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
7
Review Days
95
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Basic Information
- Device Name
- 3 PIECE PARODI GUIDEWIRE SYSTEM ( LONG CUT OUTER WITH LONG TAPER .014) SHORT TAPER, 2 PIECE PARODI GUIDEWIRE SYSTEM (LON
- K Number
- K093515
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Brivant, Ltd.
- Date Received
- November 13, 2009
- Decision Date
- February 16, 2010
- 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 Brivant, Ltd.
| K Number | Device Name | ||
|---|---|---|---|
| K122856 | CHARTER GUIDEWIRE | Oct 17, 2012 | Substantially Equivalent |
| K120137 | VICTORY GUIDEWIRE (32 MODELS) | Feb 14, 2012 | Substantially Equivalent |
| K103377 | CHARTER GUIDEWIRE MODEL 45-281, 45-282, 45-283 | May 18, 2011 | Substantially Equivalent |
| K102211 | CRUISER 18 GUIDEWIRE | Sep 3, 2010 | Substantially Equivalent |
| K083094 | STREAMER POLYMER GUIDEWIRE | Jul 7, 2009 | Substantially Equivalent |
| K073082 | CPS COURIER GUIDEWIRE | Jan 9, 2008 | Substantially Equivalent |