FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH
K Number: K101116
·
Decision Jun 23, 2010
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
6
Review Days
63
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Basic Information
- Device Name
- HI-TORQUE PILOT 50 AND 150 GUIDE WIRE WITH HYDROCOAT HYDROPHILIC COATING, HI-TORQUE WHISPER LS AND MS GUIDE WIRE WITH
- K Number
- K101116
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Abbott Vascular-Cardiac Therapies
- Date Received
- April 21, 2010
- Decision Date
- June 23, 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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