FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER MS GUIDE WIRE WITH HYDROCOAT HYDRO
K Number: K002206
·
Decision Aug 24, 2000
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
71
Review Days
34
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Basic Information
- Device Name
- HI-TORQUE WHISPER LS GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER MS GUIDE WIRE WITH HYDROCOAT HYDRO
- K Number
- K002206
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Guidant Corp.
- Date Received
- July 21, 2000
- Decision Date
- August 24, 2000
- 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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FDA 510(k)
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|---|---|---|---|
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| K042908 | RX ACCUNET 2 EMBOLIC PROTECTION SYSTEM | Nov 12, 2004 | Substantially Equivalent |
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| K031459 | RAPIDO CUT-AWAY CUTTER | Jul 23, 2003 | Substantially Equivalent |
| K031398 | IS-1 HEMOSTASIS VALVE, MODEL 6799 | May 20, 2003 | Substantially Equivalent |
| K030512 | GUIDANT VASOVIEW ENDOSCOPIC VESSEL HARVESTING SYSTEM | May 14, 2003 | Substantially Equivalent |