Destino Twist, Steerable Guiding Sheath
FDA 510(k) K140406 · Oscor, Inc.
510(k) numberK140406
Submission
- Device name
- Destino Twist, Steerable Guiding Sheath
- Applicant
- Oscor, Inc.
Palm Harbor, FL, US - Received
- February 18, 2014
- Decision date
- April 17, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) statement 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 Destino Twist, Steerable Guiding Sheath cleared by the FDA?
Destino Twist, Steerable Guiding Sheath (K140406) received a 510(k) decision of Substantially Equivalent on April 17, 2014, 58 days after the submission was received.
What is the product code of K140406?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.