JAGWIRE HIGH PERFORMANCE GUIDWIRE
FDA 510(k) clearance K141820 · decided 2014-10-21
Clearance details
- K-number
- K141820
- Device name
- JAGWIRE HIGH PERFORMANCE GUIDWIRE
- Applicant
- Boston Scientific Corp
- Decision
- Substantially Equivalent
- Date received
- 2014-07-07
- Decision date
- 2014-10-21
- Days to decision
- 106 days
- Clearance type
- Traditional
- Product code
- OCY
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Marlboro, 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
No recalls on record reference this clearance.