Introducer Assembly with Rotator Lock
FDA 510(k) K060519 · Teleflex Medical
510(k) numberK060519
Submission
- Device name
- Introducer Assembly with Rotator Lock
- Applicant
- Teleflex Medical
Bannockburn, IL, US - Received
- February 27, 2006
- Decision date
- May 5, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 Introducer Assembly with Rotator Lock cleared by the FDA?
Introducer Assembly with Rotator Lock (K060519) received a 510(k) decision of Substantially Equivalent on May 5, 2006, 67 days after the submission was received.
What is the product code of K060519?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.