Localisa Cardiac Navigation System
FDA 510(k) K002869 · Medtronic Surgical Navigation Technologies
510(k) numberK002869
Submission
- Device name
- Localisa Cardiac Navigation System
- Applicant
- Medtronic Surgical Navigation Technologies
Shoreview, MN, US - Received
- September 13, 2000
- Decision date
- March 27, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQK – Computer, Diagnostic, Programmable
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1425
- Specialty
- Cardiovascular
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Questions and answers
When was Localisa Cardiac Navigation System cleared by the FDA?
Localisa Cardiac Navigation System (K002869) received a 510(k) decision of Substantially Equivalent on March 27, 2001, 195 days after the submission was received.
What is the product code of K002869?
The FDA product code is DQK – Computer, Diagnostic, Programmable, a Class II (moderate risk) device regulated under 21 CFR 870.1425.