Attain Hybrid Guide Wire
FDA 510(k) K143316 · Medtronic, Inc.
510(k) numberK143316
Submission
- Device name
- Attain Hybrid Guide Wire
- Applicant
- Medtronic, Inc.
Mounds View, MN, US - Received
- November 19, 2014
- Decision date
- March 11, 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 Attain Hybrid Guide Wire cleared by the FDA?
Attain Hybrid Guide Wire (K143316) received a 510(k) decision of Substantially Equivalent on March 11, 2015, 112 days after the submission was received.
What is the product code of K143316?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.