Transradial Artery Access Devices
FDA 510(k) K112554 · Teleflexmedical, Inc.
510(k) numberK112554
Submission
- Device name
- Transradial Artery Access Devices
- Applicant
- Teleflexmedical, Inc.
Reading, PA, US - Received
- September 2, 2011
- Decision date
- November 18, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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Questions and answers
When was Transradial Artery Access Devices cleared by the FDA?
Transradial Artery Access Devices (K112554) received a 510(k) decision of Substantially Equivalent on November 18, 2011, 77 days after the submission was received.
What is the product code of K112554?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.