Femostop II
FDA 510(k) K944259 · Radi Medical Systems AB
510(k) numberK944259
Submission
- Device name
- Femostop II
- Applicant
- Radi Medical Systems AB
Uppsala, SE - Received
- September 1, 1994
- Decision date
- July 20, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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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| K221661 | Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)DXC · Traditional | Compression Works, Inc. | 03/03/2023SE |
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More from Vascular Graft Solutions, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K123984 | Quantien Measurement SystemDQK · Special | 03/28/2013SE |
| K092105 | Radianalyzer XpressDQK · Traditional | 10/09/2009SE |
| K080813 | Pressurewire Certus, Certus (300CM), Aeris, Aeris (300CM), ReceiverDXO · Traditional | 07/01/2008SE |
| K080206 | Modification to Femostop Femoral Compression SystemDXC · Special | 02/26/2008SE |
| K062769 | Pressurewire Certus, Models 12006 and 12306DXO · Special | 12/04/2006SE |
| K042628 | Modification to: Radianalyzer, Model 12711DQK · Traditional | 01/19/2005SE |
| K033291 | Topseal Hemostatic Dressing, Model 11150QSY · Traditional | 03/17/2004SE |
| K031662 | Pressure Wire Sensor, Models 12004/12304DXO · Special | 06/06/2003SE |
| K024107 | Femostop Femoral Compression SystemDXC · Special | 12/24/2002SE |
| K022188 | Radianalyzer, Model 12710DQK · Traditional | 10/03/2002SE |
Questions and answers
When was Femostop II cleared by the FDA?
Femostop II (K944259) received a 510(k) decision of Substantially Equivalent on July 20, 1995, 322 days after the submission was received.
What is the product code of K944259?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.