Lumax Guiding Catheter
FDA 510(k) K191163 · Cook Incorporated
510(k) numberK191163
Submission
- Device name
- Lumax Guiding Catheter
- Applicant
- Cook Incorporated
Bloomington, IN, US - Received
- May 1, 2019
- Decision date
- December 12, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQY – Catheter, Percutaneous
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1250
- Specialty
- Cardiovascular
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Questions and answers
When was Lumax Guiding Catheter cleared by the FDA?
Lumax Guiding Catheter (K191163) received a 510(k) decision of Substantially Equivalent on December 12, 2019, 225 days after the submission was received.
What is the product code of K191163?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.