Medtronic Confida Brecker Curve Guidewire
FDA 510(k) K132623 · Medtronic
510(k) numberK132623
Submission
- Device name
- Medtronic Confida Brecker Curve Guidewire
- Applicant
- Medtronic
Santa Rosa, CA, US - Received
- August 22, 2013
- Decision date
- December 19, 2013
- 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 Medtronic Confida Brecker Curve Guidewire cleared by the FDA?
Medtronic Confida Brecker Curve Guidewire (K132623) received a 510(k) decision of Substantially Equivalent on December 19, 2013, 119 days after the submission was received.
What is the product code of K132623?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.