Presdure Products Pressure Pads, Models P100, P110, P120, P130, P200, P210, P220, P230, P300, P310, P320, P330
FDA 510(k) K980087 · Pressure Products, Inc.
510(k) numberK980087
Submission
- Device name
- Presdure Products Pressure Pads, Models P100, P110, P120, P130, P200, P210, P220, P230, P300, P310, P320, P330
- Applicant
- Pressure Products, Inc.
Rancho Palos Verdes, CA, US - Received
- January 9, 1998
- Decision date
- July 1, 1998
- 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
Other 510(k)s with product code DXC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
Questions and answers
When was Presdure Products Pressure Pads, Models P100, P110, P120, P130, P200, P210, P220, P230, P300, P310, P320, P330 cleared by the FDA?
Presdure Products Pressure Pads, Models P100, P110, P120, P130, P200, P210, P220, P230, P300, P310, P320, P330 (K980087) received a 510(k) decision of Substantially Equivalent on July 1, 1998, 173 days after the submission was received.
What is the product code of K980087?
The FDA product code is DXC – Clamp, Vascular, a Class II (moderate risk) device regulated under 21 CFR 870.4450.