PLATINUM PLUS GUIDEWIRE
FDA 510(k) clearance K935997 · decided 1994-06-17
Clearance details
- K-number
- K935997
- Device name
- PLATINUM PLUS GUIDEWIRE
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 1993-12-15
- Decision date
- 1994-06-17
- Days to decision
- 184 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 |
|---|---|---|
| Platinum Plus" LT , REF 46-601, UPN M001466010, LT/0.018/180, Sterilized with ethylene oxi recall (Z-0030-2009) | Boston Scientific Corporation | 2008-10-02 |
| Platinum Plus" LT , REF 46-602, UPN M001466020, LT/0.018/260, Sterilized with ethylene oxi recall (Z-0031-2009) | Boston Scientific Corporation | 2008-10-02 |
| Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917511, Ca recall (Z-2362-2008) | Boston Scientific Corporation | 2008-09-21 |
| Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917521, Ca recall (Z-2363-2008) | Boston Scientific Corporation | 2008-09-21 |
| Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917531, Ca recall (Z-2364-2008) | Boston Scientific Corporation | 2008-09-21 |
| Boston Scientific Platinum Plus Guidewire. Material No. [outer carton label] H74917541, Ca recall (Z-2365-2008) | Boston Scientific Corporation | 2008-09-21 |