Gel-Block 10X embolization pledgets
FDA 510(k) K143038 · Vascular Solutions, Inc.
510(k) numberK143038
Submission
- Device name
- Gel-Block 10X embolization pledgets
- Applicant
- Vascular Solutions, Inc.
Minneapolis, MN, US - Received
- October 22, 2014
- Decision date
- November 20, 2014
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- KRD – Device, Vascular, For Promoting Embolization
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3300
- Specialty
- Cardiovascular
- Implant
- Yes
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Questions and answers
When was Gel-Block 10X embolization pledgets cleared by the FDA?
Gel-Block 10X embolization pledgets (K143038) received a 510(k) decision of Substantially Equivalent on November 20, 2014, 29 days after the submission was received.
What is the product code of K143038?
The FDA product code is KRD – Device, Vascular, For Promoting Embolization, a Class II (moderate risk) device regulated under 21 CFR 870.3300.