Medtronic 6F Taiga Guiding Catheter
FDA 510(k) K192296 · Medtronic Vascular
510(k) numberK192296
Submission
- Device name
- Medtronic 6F Taiga Guiding Catheter
- Applicant
- Medtronic Vascular
Danvers, MA, US - Received
- August 23, 2019
- Decision date
- September 20, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 Medtronic 6F Taiga Guiding Catheter cleared by the FDA?
Medtronic 6F Taiga Guiding Catheter (K192296) received a 510(k) decision of Substantially Equivalent on September 20, 2019, 28 days after the submission was received.
What is the product code of K192296?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.