REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406
FDA 510(k) clearance K024243 · decided 2003-06-20
Clearance details
- K-number
- K024243
- Device name
- REFORM PERIPHERAL CATHETER SYSTEM, MODEL 02200; REFORM PERIPHERAL CATHETERCATHETER, MODEL 02406
- Applicant
- Fox Hollow Technologies
- Decision
- Substantially Equivalent
- Date received
- 2002-12-23
- Decision date
- 2003-06-20
- Days to decision
- 179 days
- Clearance type
- Traditional
- Product code
- MCW
- Device class
- 2
- Regulation number
- 870.4875
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Redwood City, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ReFORM/SilverHawk Peripheral Atherectomy Catheters, Catalog Numbers: P4012, P04015; Manufa recall (Z-1091-04) | Fox Hollow Technologies | 2004-07-20 |