Arrow® Nitinol Wire
FDA 510(k) K241784 · Teleflex Medical
510(k) numberK241784
Submission
- Device name
- Arrow® Nitinol Wire
- Applicant
- Teleflex Medical
Morrisville, NC, US - Received
- June 20, 2024
- Decision date
- September 18, 2024
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DQX – Wire, Guide, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1330
- Specialty
- Cardiovascular
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Questions and answers
When was Arrow® Nitinol Wire cleared by the FDA?
Arrow® Nitinol Wire (K241784) received a 510(k) decision of Substantially Equivalent on September 18, 2024, 90 days after the submission was received.
What is the product code of K241784?
The FDA product code is DQX – Wire, Guide, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1330.