Magic Torque DLVR Guidewire
FDA 510(k) K182315 · Boston Scientific Corporation
510(k) numberK182315
Submission
- Device name
- Magic Torque DLVR Guidewire
- Applicant
- Boston Scientific Corporation
Maple Grove, MN, US - Received
- August 27, 2018
- Decision date
- September 26, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 Magic Torque DLVR Guidewire cleared by the FDA?
Magic Torque DLVR Guidewire (K182315) received a 510(k) decision of Substantially Equivalent on September 26, 2018, 30 days after the submission was received.
What is the product code of K182315?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.