Reflexion Spiral Variable Radius Catheter
FDA 510(k) K072012 · St Jude Medical
510(k) numberK072012
Submission
- Device name
- Reflexion Spiral Variable Radius Catheter
- Applicant
- St Jude Medical
Minnetonka, MN, US - Received
- July 23, 2007
- Decision date
- August 22, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 Reflexion Spiral Variable Radius Catheter cleared by the FDA?
Reflexion Spiral Variable Radius Catheter (K072012) received a 510(k) decision of Substantially Equivalent on August 22, 2007, 30 days after the submission was received.
What is the product code of K072012?
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.