FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS)
K Number: K071029
·
Decision Aug 24, 2007
Classifications
1
FEI Numbers
257
Registration Numbers
258
Same Product Code
763
Applicant Total
28
Review Days
135
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Basic Information
- Device Name
- CARDIODRIVE CATHETER ADVANCEMENT SYSTEM (CAS)
- K Number
- K071029
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Stereotaxis, Inc.
- Date Received
- April 11, 2007
- Decision Date
- August 24, 2007
- 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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|---|---|---|---|
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| K150312 | Vdrive system, Vdrive Duo, Vdrive with V-Sono | Jun 17, 2015 | Substantially Equivalent |
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| K140804 | VDRIVE WITH V-LOOP/ VDRIVE DUO | Sep 3, 2014 | Substantially Equivalent |
| K133396 | VDRIVE WITH V-SONO | Feb 6, 2014 | Substantially Equivalent |