IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1
FDA 510(k) clearance K011965 · decided 2001-07-13
Clearance details
- K-number
- K011965
- Device name
- IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2001-06-25
- Decision date
- 2001-07-13
- Days to decision
- 18 days
- Clearance type
- Special
- Product code
- KOD
- Device class
- 2
- Regulation number
- 876.5130
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Natick,, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific, IMAGER II Urology Torque Catheter, Sterilized with ethylene oxide gas. recall (Z-1393-2012) | Boston Scientific Corporation | 2012-04-11 |
| Imager" II Urology Torque Catheter, Sterilized with ethylene oxide gas, Manufactured for B recall (Z-0337-2010) | Boston Scientific Corporation | 2010-01-21 |
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