ENDOVASCULAR GUIDE WIRE
FDA 510(k) clearance K021363 · decided 2002-11-27
Clearance details
- K-number
- K021363
- Device name
- ENDOVASCULAR GUIDE WIRE
- Applicant
- Stereotaxis, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2002-04-30
- Decision date
- 2002-11-27
- Days to decision
- 211 days
- Clearance type
- Traditional
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Saint Louis, MO, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Cronus Endovascular Guidewire, Length 210 cm (full coat), Diameter 0.014 inch, Part Number recall (Z-0590-04) | Stereotaxis Inc | 2004-07-20 |
| Cronus Endovascular Guidewire, Length 210 cm (partial coat), Diameter 0.014 inch, Part Num recall (Z-0591-04) | Stereotaxis Inc | 2004-07-20 |
| Cronus Endovascular Guidewire, Length 300 cm (partial coat), Diameter 0.014 inch, Part Num recall (Z-0592-04) | Stereotaxis Inc | 2004-07-20 |
| Floppy Cronus Endovascular Guidewire, Length 180 cm (partial coat), Diameter 0.014 inch, P recall (Z-0593-04) | Stereotaxis Inc | 2004-07-20 |
| Floppy Cronus Endovascular Guidewire, Length 300 cm (partial coat), Diameter 0.014 inch, P recall (Z-0594-04) | Stereotaxis Inc | 2004-07-20 |
| Cronus-1 Endovascular Guidewire, Length 210 cm (full coat), Diameter 0.014 inch, Part Numb recall (Z-0595-04) | Stereotaxis Inc | 2004-07-20 |
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| HELIOS II ABLATION CATHETER (P050029) | Stereotaxis, Inc. | 2008-10-10 |