VSI StraitSet micro-introducer kit
FDA 510(k) K161336 · Vascular Solutions, Inc.
510(k) numberK161336
Submission
- Device name
- VSI StraitSet micro-introducer kit
- Applicant
- Vascular Solutions, Inc.
Minneapolis, MN, US - Received
- May 13, 2016
- Decision date
- August 11, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRE – Dilator, Vessel, For Percutaneous Catheterization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1310
- Specialty
- Cardiovascular
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Questions and answers
When was VSI StraitSet micro-introducer kit cleared by the FDA?
VSI StraitSet micro-introducer kit (K161336) received a 510(k) decision of Substantially Equivalent on August 11, 2016, 90 days after the submission was received.
What is the product code of K161336?
The FDA product code is DRE – Dilator, Vessel, For Percutaneous Catheterization, a Class II (moderate risk) device regulated under 21 CFR 870.1310.