6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter
FDA 510(k) K232190 · Medtronic Vascular
510(k) numberK232190
Submission
- Device name
- 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter
- Applicant
- Medtronic Vascular
Danvers, MA, US - Received
- July 24, 2023
- Decision date
- August 22, 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 6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter cleared by the FDA?
6F Sherpa NX Balanced Guide Catheter, 7F Sherpa NX Balanced Guide Catheter (K232190) received a 510(k) decision of Substantially Equivalent on August 22, 2023, 29 days after the submission was received.
What is the product code of K232190?
The FDA product code is DQY – Catheter, Percutaneous, a Class II (moderate risk) device regulated under 21 CFR 870.1250.