Jagwire High Performance Guidwire
FDA 510(k) K141820 · Boston Scientific Corp
510(k) numberK141820
Submission
- Device name
- Jagwire High Performance Guidwire
- Applicant
- Boston Scientific Corp
Marlboro, MA, US - Received
- July 7, 2014
- Decision date
- October 21, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OCY – Endoscopic Guidewire, Gastroenterology-Urology
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
To provide access to gi or gu tract for the purpose of passing or exchanging other accessories.
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Questions and answers
When was Jagwire High Performance Guidwire cleared by the FDA?
Jagwire High Performance Guidwire (K141820) received a 510(k) decision of Substantially Equivalent on October 21, 2014, 106 days after the submission was received.
What is the product code of K141820?
The FDA product code is OCY – Endoscopic Guidewire, Gastroenterology-Urology, a Class II (moderate risk) device regulated under 21 CFR 876.1500.