Pall EC Plus Filter w/Filter Sleeve
by Pall Biomedical Products Co.
510(k) K834382
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK834382 | Date3 Aug 1984 | 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- Withdrawn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
- DTM
- Device Class
- Class II
- Regulation
- 21 CFR Part 870.4260
- Advisory Committee
- Cardiovascular
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 24 Sep 2026
Filter, Blood, Cardiopulmonary Bypass, Arterial Line. This device is a blood filter used in cardiopulmonary bypass and arterial line applications.
Supplied by Pall Biomedical Products Co. It is a Class II device with FDA 510(k) clearance K834382, granted on August 3, 1984, under regulation 870.4260. The product code is DTM.
Other devices from Pall Biomedical Products Co.
Questions
AI-generated answers, 24 Sep 2026
What is the PALL EC PLUS FILTER W/FILTER SLEEVE used for?
The PALL EC PLUS FILTER W/FILTER SLEEVE is a blood filter designed for use in cardiopulmonary bypass and arterial line applications, as stated in the device description and FDA 510(k) clearance documentation.
Who manufactures the PALL EC PLUS FILTER W/FILTER SLEEVE and what is its regulatory status?
The PALL EC PLUS FILTER W/FILTER SLEEVE is manufactured by Pall Biomedical Products Co. and has FDA 510(k) clearance under number K834382, granted on August 3, 1984, for the device name and intended use specified in the clearance.
What regulatory pathway and product code apply to the PALL EC PLUS FILTER W/FILTER SLEEVE?
The device follows the Traditional 510(k) pathway with product code DTM, as indicated in the authorization and openfda fields, and was found substantially equivalent to a predicate device.