BACK-UP MEIER STEERABLE GUIDEWIRE
FDA 510(k) clearance K020283 · decided 2002-02-11
Clearance details
- K-number
- K020283
- Device name
- BACK-UP MEIER STEERABLE GUIDEWIRE
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2002-01-28
- Decision date
- 2002-02-11
- Days to decision
- 14 days
- Clearance type
- Traditional
- Product code
- DQX
- Device class
- 2
- Regulation number
- 870.1330
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Natick,, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Boston Scientific Corp
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Boston Scientific, Back-Up Meier Steerable Guidewires, Sterilized using ethylene oxide. Th recall (Z-1760-2010) | Boston Scientific Corporation | 2010-06-04 |