FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CONQUEST 40 PTA DILATATION CATHETER
K Number: K120660
·
Decision Mar 15, 2012
Classifications
1
FEI Numbers
94
Registration Numbers
94
Same Product Code
399
Applicant Total
19
Review Days
10
Basic Information
- Device Name
- CONQUEST 40 PTA DILATATION CATHETER
- K Number
- K120660
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1250
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- BARD PERIPHERAL VASCULAR, INC.
- Date Received
- March 5, 2012
- Decision Date
- March 15, 2012
- Product Code
- LIT
- 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 |
|---|---|---|---|
| LIT | Catheter, Angioplasty, Peripheral, Transluminal | FDA class 2 | Cardiovascular |
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|---|---|---|---|
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| K120971 | ATLAS PTA BALLOON DILATATION CATHETER | Apr 19, 2012 | Substantially Equivalent |
| K120722 | RIVAL PTA DILATATION CATHETER | Apr 19, 2012 | Substantially Equivalent |
| K103367 | SEEKER CROSSING SUPPORT CATHETER | Dec 8, 2010 | Substantially Equivalent |
| K063532 | BARD E LUMINEXX BILIARY STENT | May 30, 2008 | Unknown |