PALL EC PLUS 3LPM MAX. FILTER W/SLEEVE— 510(k) K853987

Name: FDA 510(k) clearance K853987
Creator: U.S. Food and Drug Administration
Published: 1985-12-11

Substantially Equivalent

Pall Biomedical Products Co.

FDA 510(k) clearance K853987 for PALL EC PLUS 3LPM MAX. FILTER W/SLEEVE, Substantially Equivalent on 1985-12-11. Applicant: Pall Biomedical Products Co.. Device class: 2.

Clearance details

Applicant: Pall Biomedical Products Co.
Product code: Code DTM
Device class: Class 2
Regulation: 21 CFR 870.4260
Advisory panel: Cardiovascular
Date received: 1985-09-27
Decision date: 1985-12-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glen Cove, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DTM

view all

K251744 — Affinity Pixie Arterial Filter with Balance Biosurface; Affinity® Pediatric Arterial Blood Filter2026-01-16
K242953 — KIDS Arterial Filters2024-12-20
K242092 — MICRO Arterial Filters2024-11-18
K231362 — OCS Heart Leukocyte Depleting Filter2023-10-31
K123351 — AFFINITY AF100 ARTERIAL FILTER WITH CARMEDA BIOACTIVE SURFACE2013-03-19

More clearances from Pall Biomedical Products Co.

view all

K954331 — PALL LEA FILTER (LIPID EMULSION FILTER) (I.V. FILTER)1997-01-09
K960993 — PALL SQ40S BLOOD FILTER (SQ40S/SQ40ST)1996-04-22
K905794 — PALL 3N1 FILTER1991-06-13
K902518 — LD-SIX ARTERIAL BLOOD FILTER FOR EXTRA. SERVICE1990-10-16
K884534 — PALL HEPCHEK (TM) HEPARIN ABSORPTION FILTER1989-01-24

Data sourced from openFDA. This site is unofficial and independent of the FDA.