Vasostasis Vascular Closure System
FDA 510(k) K041486 · Cardiva Medical, Inc.
510(k) numberK041486
Submission
- Device name
- Vasostasis Vascular Closure System
- Applicant
- Cardiva Medical, Inc.
Pleasanton, CA, US - Received
- June 4, 2004
- Decision date
- October 22, 2004
- 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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More from Vascular Graft Solutions, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K130124 | Catalyst II and IIIDXC · Traditional | 03/14/2013SE |
| K082930 | Cardiva Catalyst III System with Protamine SulfateDXC · Traditional | 02/13/2009SE |
| K072297 | Boomerang Catalyst/Boomerang Catalyst II SystemDXC · Special | 09/12/2007SE |
| K070485 | Boomerang Wire /Boomerang Plus Wire System, Model# B Plus Wire 58LDXC · Special | 03/22/2007SE |
| K051817 | Boomerang Closurewire Vascular Closure SystemDXC · Traditional | 12/06/2006SE |
| K061075 | Boomerang WireDXC · Special | 09/01/2006SE |
Questions and answers
When was Vasostasis Vascular Closure System cleared by the FDA?
Vasostasis Vascular Closure System (K041486) received a 510(k) decision of Substantially Equivalent on October 22, 2004, 140 days after the submission was received.
What is the product code of K041486?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.