5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter
FDA 510(k) K230156 · Medtronic Vascular
510(k) numberK230156
Submission
- Device name
- 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter
- Applicant
- Medtronic Vascular
Danvers, MA, US - Received
- January 19, 2023
- Decision date
- June 30, 2023
- 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 5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter cleared by the FDA?
5F Launcher Guide Catheter, 6F Launcher Guide Catheter, 7F Launcher Guide Catheter, 8F Launcher Guide Catheter (K230156) received a 510(k) decision of Substantially Equivalent on June 30, 2023, 162 days after the submission was received.
What is the product code of K230156?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.