Favp: Femoral Artery Vascular Pad - Model Number PAD2EK-01, PAD2EK-2X, PAD5EK-R, PAD5EK-Rx, PAD6EK-F and PAD6EK-Fx
by Rmds, Inc.
510(k) K964663
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK964663 | Date11 Dec 1997 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- DXC
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4450
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The Femoral Artery Vascular Pad is a device designed as a mechanical compression aid for achieving hemostasis at femoral artery access sites following catheterization procedures. It applies controlled pressure to promote blood vessel closure and reduce bleeding risk post-intervention, serving as either a manual or mechanical compression solution.
These pads are supplied as single-use, non-sterile devices intended for use in clinical settings such as catheterization labs or vascular access procedures. Each model number (PAD2EK-01, PAD2EK-2X, PAD5EK-R, PAD5EK-RX, PAD6EK-F, PAD6EK-FX) corresponds to specific sizes or configurations for targeted application. The device holds an FDA 510(k) clearance under the product code DXC, with a traditional review process through the Cardiovascular Advisory Committee.
Other devices from Rmds, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the Femoral Artery Vascular Pad used for?
The Femoral Artery Vascular Pad is designed as a mechanical compression aid to achieve hemostasis at femoral artery access sites following catheterization procedures. It applies controlled pressure to promote blood vessel closure and reduce bleeding risk after interventions like angioplasty or stent placement. This helps clinicians manage access site bleeding more effectively in catheterization labs or vascular procedures.
Are these pads single-use or reusable?
These pads are explicitly supplied as single-use devices. This design ensures patient safety by preventing cross-contamination between uses, which is critical in clinical settings where sterility and infection control are paramount. Each pad is intended for one-time application during a single procedure.
What sizes or models are available, and how do they differ?
Six models are available: PAD2EK-01, PAD2EK-2X, PAD5EK-R, PAD5EK-RX, PAD6EK-F, and PAD6EK-FX. Each model corresponds to specific sizes or configurations tailored for targeted femoral artery access sites. For example, the PAD2EK series may differ in width or pressure distribution, while the PAD5EK and PAD6EK models likely accommodate larger or deeper access sites. Consult the product documentation for precise sizing details.
Are these pads sterile, and if not, how should they be handled?
The Femoral Artery Vascular Pads are supplied as non-sterile devices. In clinical settings, they should be handled using standard aseptic techniques. This includes wearing gloves and ensuring the pad is only applied to the access site after proper skin preparation (e.g., antiseptic cleaning). Sterility is not required for single-use non-sterile devices when used correctly in controlled environments.
How should these pads be stored before use?
The pads should be stored in a clean, dry environment protected from direct sunlight, extreme temperatures, and physical damage. Since they are single-use and non-sterile, they do not require sterile storage conditions but should be kept in their original packaging until immediately before use. Proper storage ensures the pad remains intact and functional for its intended application.