FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
K Number: K033929
·
Decision Jan 12, 2004
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
20
Review Days
25
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Basic Information
- Device Name
- MODIFICATION TO SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM
- K Number
- K033929
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Intra Luminal Therapeutics, Inc.
- Date Received
- December 18, 2003
- Decision Date
- January 12, 2004
- 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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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 |
| 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 |
| K031692 | SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1 | Aug 22, 2003 | Substantially Equivalent |