Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire
FDA 510(k) K151840 · Boston Scientific Corporation
510(k) numberK151840
Submission
- Device name
- Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire
- Applicant
- Boston Scientific Corporation
Maple Grove, MN, US - Received
- July 6, 2015
- Decision date
- December 16, 2015
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQX – Wire, Guide, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1330
- Specialty
- Cardiovascular
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Questions and answers
When was Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire cleared by the FDA?
Fighter Guidewire, Marvel Guidewire, Samurai Guidewire, Samurai RC Guidewire, Stretch Extension Wire (K151840) received a 510(k) decision of Substantially Equivalent on December 16, 2015, 163 days after the submission was received.
What is the product code of K151840?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.