FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ILT TORQUER, MODEL 114TR1
K Number: K021243
·
Decision Jul 11, 2002
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
20
Review Days
83
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ILT TORQUER, MODEL 114TR1
- K Number
- K021243
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Intra Luminal Therapeutics, Inc.
- Date Received
- April 19, 2002
- Decision Date
- July 11, 2002
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (DQX), ordered by most recent decision date.
InQwire Amplatz Guide Wire
FDA 510(k)
FDA Class 2
·Cardiovascular
FMD Peripheral Guide Wire F-14 Flex 6; FMD Peripheral Guide Wire F-14 Tapered 40; FMD Peripheral Guide Wire F-18 Flex SP; FMD Peripheral Guide Wire F-18 DP 25; FMD Peripheral Guide Wire F-18 Tapered 40
FDA 510(k)
FDA Class 2
·Cardiovascular
Enroute 0.014'' Transcarotid Guidewire
FDA 510(k)
FDA Class 2
·Cardiovascular
EmeryGlide (EG18008901)
FDA 510(k)
FDA Class 2
·Cardiovascular
Splashwire Hydrophilic Guide Wire (MSWSTD35150J3)
FDA 510(k)
FDA Class 2
·Cardiovascular
InQwire Super Stiff Guide Wire (IQSS32180J3); InQwire Super Stiff Guide Wire (IQSS35F260S); InQwire Super Stiff Guide Wire (IQSS35F150S); InQwire Super Stiff Guide Wire (IQSS35F100S); InQwire Super Stiff Guide Wire (IQSS35F80S); InQwire Super Stiff Guide Wire (IQSS35F180S)
FDA 510(k)
FDA Class 2
·Cardiovascular
Other Clearances by Intra Luminal Therapeutics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K050916 | SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [PERIPHERAL] | Jun 8, 2005 | Substantially Equivalent |
| K050915 | SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [CORONARY] | Jun 7, 2005 | Substantially Equivalent |
| K041973 | MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM | Aug 16, 2004 | Substantially Equivalent |
| K040481 | SAFE-CROSS DEFLECTING CATHETER, MODEL C118ND1 | Mar 18, 2004 | Substantially Equivalent |
| K040037 | MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM | Mar 3, 2004 | Substantially Equivalent |
| K033929 | MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM | Jan 12, 2004 | Substantially Equivalent |
| K032031 | SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM | Jan 7, 2004 | Substantially Equivalent |
| K033708 | MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM | Dec 11, 2003 | Substantially Equivalent |
| K031842 | SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM | Nov 21, 2003 | Substantially Equivalent |
| K032784 | ILT SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1 | Nov 18, 2003 | Substantially Equivalent |