FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [PERIPHERAL]
K Number: K050916
·
Decision Jun 8, 2005
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
56
Applicant Total
20
Review Days
57
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Basic Information
- Device Name
- SAFE-CROSS RADIO FREQUENCY TOTAL OCCLUSION CROSSING SYSTEM [PERIPHERAL]
- K Number
- K050916
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Intra Luminal Therapeutics, Inc.
- Date Received
- April 12, 2005
- Decision Date
- June 8, 2005
- Product Code
- PDU
- 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 |
|---|---|---|---|
| PDU | Catheter For Crossing Total Occlusions | FDA class 2 | Cardiovascular |
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Other Clearances by Intra Luminal Therapeutics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K031692 | SAFE-CROSS DEFLECTING CATHETER, MODEL C114ND1 | Aug 22, 2003 | Substantially Equivalent |