PCD 737A
by Mego Afek AC, Ltd. 510(k)
Active
510(k) K140642
Overview
This device is a Sleeve, Limb, Compressible, as defined in the FDA classification system. It is intended for use in cardiovascular applications.
The PCD 737A received FDA 510(k) clearance under K140642 on June 10, 2014, with a traditional clearance pathway. It is classified as a Class II medical device under regulation 870.5800, with product code JOW, and was found substantially equivalent to a predicate device.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK140642 | Date10 Jun 2014 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- JOW
- FDA applicant
- Mego Afek AC , Ltd.
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.5800
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Other devices from Mego Afek AC, Ltd.
Questions
What is the PCD 737A used for?
The PCD 737A is a compressible limb sleeve intended for use in cardiovascular applications, as defined in the FDA classification system and specified in its 510(k) clearance documentation.
How is the PCD 737A supplied and is it sterile or reusable?
The device data does not specify whether the PCD 737A is supplied sterile or non-sterile, or whether it is designed for single-use or reuse; such details are not included in the provided authorization or specifications.
What regulatory pathway was used for the PCD 737A and what is its classification?
The PCD 737A received FDA 510(k) clearance under K140642 via a traditional clearance pathway and is classified as a Class II medical device under regulation 870.5800 with product code JOW.