VSI Micro-Introducer Kit
FDA 510(k) K180913 · Vascular Solutions, Inc.
510(k) numberK180913
Submission
- Device name
- VSI Micro-Introducer Kit
- Applicant
- Vascular Solutions, Inc.
Minneapolis, MN, US - Received
- April 9, 2018
- Decision date
- May 9, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- DYB – Introducer, Catheter
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1340
- Specialty
- Cardiovascular
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| K212167 | R350 guidewire, Spectre guidewire, Raider guidewire, Bandit guidewire, Warrior guidewireDQX · Traditional | 02/09/2022SE |
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Questions and answers
When was VSI Micro-Introducer Kit cleared by the FDA?
VSI Micro-Introducer Kit (K180913) received a 510(k) decision of Substantially Equivalent on May 9, 2018, 30 days after the submission was received.
What is the product code of K180913?
The FDA product code is DYB – Introducer, Catheter, a Class II (moderate risk) device regulated under 21 CFR 870.1340.