FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OUTBACK CATHETER
K Number: K001577
·
Decision Jan 11, 2001
Classifications
1
FEI Numbers
276
Registration Numbers
277
Same Product Code
889
Applicant Total
11
Review Days
234
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Basic Information
- Device Name
- OUTBACK CATHETER
- K Number
- K001577
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Lumend, Inc.
- Date Received
- May 22, 2000
- Decision Date
- January 11, 2001
- Product Code
- DQY
- 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 |
|---|---|---|---|
| DQY | Catheter, Percutaneous | FDA class 2 | Cardiovascular |
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Other Clearances by Lumend, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K043534 | MODIFICATION TO OUTBACK CATHETER | Jan 21, 2005 | Substantially Equivalent |
| K040771 | MODIFICATION TO OUTBACK CATHETER | Apr 23, 2004 | Substantially Equivalent |
| K033535 | LUMEND FRONTRUNNER CTO CATHETER AND ACCESSORIES | Jan 7, 2004 | Substantially Equivalent |
| K032298 | MODIFICATION TO OUTBACK CATHETER | Aug 26, 2003 | Substantially Equivalent |
| K031005 | LUMEND FRONTRUNNER GW CTO CATHETER | Jun 18, 2003 | Substantially Equivalent |
| K023114 | LUMEND FRONTRUNNER CTO CATHETER | Jan 23, 2003 | Substantially Equivalent |
| K023223 | MODIFICATION TO LUMEND FRONTRUNNER CTO CATHETER | Oct 24, 2002 | Substantially Equivalent |
| K013284 | LUMEND FRONTRUNNER CTO CORONARY CATHETER | Feb 11, 2002 | Substantially Equivalent |
| K011562 | LUMEND PERCUTANEOUS CATHETER | Jan 16, 2002 | Substantially Equivalent |
| K014117 | MODIFICATION TO OUTBACK CATHETER | Jan 11, 2002 | Substantially Equivalent |