FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL
K Number: K101011
·
Decision May 24, 2010
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
20
Review Days
42
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Basic Information
- Device Name
- HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL
- K Number
- K101011
- 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, Inc.
- Date Received
- April 12, 2010
- Decision Date
- May 24, 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 Abbott Vascular, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K142415 | Hi-Torque JET Guide Wire Family | Dec 19, 2014 | Substantially Equivalent |
| K123067 | PROGRESS GUIDE WIRE FAMILY, PILOT GUIDE WIRE FAMILY | Jan 29, 2013 | Substantially Equivalent |
| K122573 | HI-TORQUE COMMAND GUIDE WIRE FAMILY | Nov 20, 2012 | Substantially Equivalent |
| K102705 | ARMADA 14 PTA CATHETER | Dec 7, 2010 | Substantially Equivalent |
| K101648 | HI-TORQUE WINN GUIDE WIRE FAMILY | Jul 8, 2010 | Substantially Equivalent |
| K091825 | HI-TORQUE PROGRESS GUIDE WIRE FAMILY | Sep 25, 2009 | Substantially Equivalent |
| K081417 | FOXCROSS PTA CATHETER | Jun 4, 2008 | Substantially Equivalent |
| K080925 | FOX PLUS PTA CATHETER | Apr 28, 2008 | Substantially Equivalent |
| K072460 | HI-TORQUE BALANCE MIDDLEWEIGHT UNIVERSAL II GUIDE WIRE | Apr 11, 2008 | Substantially Equivalent |
| K063481 | MODIFICATION TO RX HERCULINK ELITE BILIARY STENT SYSTEM | Sep 14, 2007 | Unknown |