MAGIC TORQUE GUIDEWIRE
FDA 510(k) clearance K933334 · decided 1994-01-26
Clearance details
- K-number
- K933334
- Device name
- MAGIC TORQUE GUIDEWIRE
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 1993-07-08
- Decision date
- 1994-01-26
- Days to decision
- 202 days
- Clearance type
- Traditional
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Watertown, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Medi-Tech Magic Torque Glidex hydrophilic coated guidewire, .035 inch/180 cm and .035 inch recall (Z-0666-03) | Symbiosis Corp. | 2003-03-20 |