Cosine-10TM Diagnostic Catheter
FDA 510(k) K233397 · Medtronic, Inc.
510(k) numberK233397
Submission
- Device name
- Cosine-10TM Diagnostic Catheter
- Applicant
- Medtronic, Inc.
Mounds View, MN, US - Received
- October 3, 2023
- Decision date
- December 2, 2023
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRF – Catheter, Electrode Recording, Or Probe, Electrode Recording
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1220
- Specialty
- Cardiovascular
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Questions and answers
When was Cosine-10TM Diagnostic Catheter cleared by the FDA?
Cosine-10TM Diagnostic Catheter (K233397) received a 510(k) decision of Substantially Equivalent on December 2, 2023, 60 days after the submission was received.
What is the product code of K233397?
The FDA product code is DRF – Catheter, Electrode Recording, Or Probe, Electrode Recording, a Class II (moderate risk) device regulated under 21 CFR 870.1220.