FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TORQUE HANDLE DEVICE FOR GUIDEWIRE
K Number: K905639
·
Decision Feb 20, 1991
Classifications
1
FEI Numbers
252
Registration Numbers
253
Same Product Code
751
Applicant Total
42
Review Days
65
Basic Information
- Device Name
- TORQUE HANDLE DEVICE FOR GUIDEWIRE
- K Number
- K905639
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- LAKE REGION MFG., INC.
- Date Received
- December 17, 1990
- Decision Date
- February 20, 1991
- 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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|---|---|---|---|
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| K073655 | PEGASUS STEERABLE (PTCA) GUIDEWIRE | Jan 28, 2008 | Substantially Equivalent |
| K060454 | TITAN GUIDEWIRE | Mar 24, 2006 | Substantially Equivalent |
| K052347 | TITAN STEERABLE (PTCA) GUIDEWIRE | Feb 17, 2006 | Substantially Equivalent |
| K042338 | CORONARY PERIPHERAL AND RENAL STEERABLE GUIDEWIRE | Sep 16, 2004 | Substantially Equivalent |
| K041624 | PTCA STEERABLE HYDROPHILIC GUIDEWIRE | Jul 16, 2004 | Substantially Equivalent |
| K040825 | LAKE REGION HYDROPHILIC GUIDEWIRE | May 17, 2004 | Substantially Equivalent |