Air-Band Radial Compression Device
FDA 510(k) K122405 · Datascope Corp., Cardiac Assist Division
510(k) numberK122405
Submission
- Device name
- Air-Band Radial Compression Device
- Applicant
- Datascope Corp., Cardiac Assist Division
Fairfield, NJ, US - Received
- August 7, 2012
- Decision date
- November 9, 2012
- 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
Other 510(k)s with product code DXC
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|---|---|---|---|
| K262086 | PreludeSYNC Radial Compression DeviceDXC · Special | Merit Medical Systems, Inc. | 07/22/2026SE |
| K260105 | Fogarty Spring Clips, Handleless Clamps, and Clamp InsertsDXC · Traditional | Edwards Lifesciences | 06/05/2026SE |
| K252772 | Arc Adjustable Radial Cuff Compression DeviceDXC · Traditional | Tz Medical, Inc. | 05/22/2026SE |
| K254060 | Life Saving TourniquetDXC · Traditional | TW Medical | 04/03/2026SE |
| K243627 | Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp…DXC · Traditional | Arc Trauma, LLC | 12/31/2025SE |
| K253070 | Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)DXC · Traditional | Medline Industries, LP | 11/20/2025SE |
| K232577 | Radial Compression DeviceDXC · Traditional | Ningbo Dizegens Medical Science Co.,Ltd | 01/18/2024SE |
| K230281 | PicoclampDXC · Traditional | Kono Seisakusho Co., Ltd. | 10/23/2023SE |
| K221661 | Abdominal Aortic and Junctional Tourniquet - Stabilized (AAJT-S)DXC · Traditional | Compression Works, Inc. | 03/03/2023SE |
| K230248 | ViolaDXC · Special | Vascular Graft Solutions, Ltd. | 02/28/2023SE |
More from Vascular Graft Solutions, Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K122628 | Sensation Plus 7.5FR. 40CC Intra-Aortic Balloon (Iab) Catheter and AccessoriesDSP · Special | 09/06/2012SE |
| K120868 | Mega(Tm) 7.5FR. 30CC Intra-Aortic Balloon Catheter and Accessories, Mega(Tm) 7.5FR. 40CC…DSP · Special | 04/20/2012SE |
| K091449 | Datascope's 8FR. 50CC Intra-Aortic Balloon Catheter and Accessories, Models…DSP · Special | 06/18/2009SE |
Questions and answers
When was Air-Band Radial Compression Device cleared by the FDA?
Air-Band Radial Compression Device (K122405) received a 510(k) decision of Substantially Equivalent on November 9, 2012, 94 days after the submission was received.
What is the product code of K122405?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.