Nanostim Introducer Kit
FDA 510(k) K140793 · St. Jude Medical, Inc.
510(k) numberK140793
Submission
- Device name
- Nanostim Introducer Kit
- Applicant
- St. Jude Medical, Inc.
Sunnyvale, CA, US - Received
- March 31, 2014
- Decision date
- December 17, 2014
- 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 Nanostim Introducer Kit cleared by the FDA?
Nanostim Introducer Kit (K140793) received a 510(k) decision of Substantially Equivalent on December 17, 2014, 261 days after the submission was received.
What is the product code of K140793?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.