FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DUOFLO CATHETER
K Number: K080700
·
Decision Sep 26, 2008
Classifications
1
FEI Numbers
62
Registration Numbers
62
Same Product Code
89
Applicant Total
5
Review Days
199
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Basic Information
- Device Name
- DUOFLO CATHETER
- K Number
- K080700
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.4450
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Thermopeutix, Inc.
- Date Received
- March 11, 2008
- Decision Date
- September 26, 2008
- Product Code
- MJN
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- Third Party
- Y
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MJN | Catheter, Intravascular Occluding, Temporary | FDA class 2 | Cardiovascular |
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Other Clearances by Thermopeutix, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K132701 | PRIMI SUPPORT CATHETER | Sep 26, 2013 | Substantially Equivalent |
| K130850 | PRIMI AND SECONDI SUPPORT CATHETERS | Jun 25, 2013 | Substantially Equivalent |
| K112219 | TAPAS CATHETER | Nov 18, 2011 | Substantially Equivalent |
| K093847 | DUFLO CATHETER (HEPARIN COATED) | Aug 25, 2010 | Substantially Equivalent |