TRAcelet Compression Device
FDA 510(k) K162027 · Medtronic Vascular
510(k) numberK162027
Submission
- Device name
- TRAcelet Compression Device
- Applicant
- Medtronic Vascular
Danvers, MA, US - Received
- July 22, 2016
- Decision date
- October 21, 2016
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXC – Clamp, Vascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4450
- Specialty
- Cardiovascular
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| K230248 | ViolaDXC · Special | Vascular Graft Solutions, Ltd. | 02/28/2023SE |
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Questions and answers
When was TRAcelet Compression Device cleared by the FDA?
TRAcelet Compression Device (K162027) received a 510(k) decision of Substantially Equivalent on October 21, 2016, 91 days after the submission was received.
What is the product code of K162027?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.