Compressar Supercomfort Disc and Strongarm Supercomfort System
FDA 510(k) K040615 · Advanced Vascular Dynamics
510(k) numberK040615
Submission
- Device name
- Compressar Supercomfort Disc and Strongarm Supercomfort System
- Applicant
- Advanced Vascular Dynamics
Portland, OR, US - Received
- March 9, 2004
- Decision date
- June 1, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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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| K093192 | Flochec Photo Plethysmographic DeviceJOM · Traditional | 02/12/2010SE |
| K092503 | Radar Vascular Compression DevicesDXC · Traditional | 11/19/2009SE |
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| K072167 | Comfortpress Vascular Compression Assist DeviceDXC · Special | 09/06/2007SE |
Questions and answers
When was Compressar Supercomfort Disc and Strongarm Supercomfort System cleared by the FDA?
Compressar Supercomfort Disc and Strongarm Supercomfort System (K040615) received a 510(k) decision of Substantially Equivalent on June 1, 2004, 84 days after the submission was received.
What is the product code of K040615?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.