TERUMO HOLLOW OXYGENATOR CIRCUIT— 510(k) K812659

Name: FDA 510(k) clearance K812659
Creator: U.S. Food and Drug Administration
Published: 1981-12-14

Substantially Equivalent

Terumo Medical Corp.

FDA 510(k) clearance K812659 for TERUMO HOLLOW OXYGENATOR CIRCUIT, Substantially Equivalent on 1981-12-14. Applicant: Terumo Medical Corp.. Device class: 2.

Clearance details

Applicant: Terumo Medical Corp.
Product code: Code DTM
Device class: Class 2
Regulation: 21 CFR 870.4260
Advisory panel: Cardiovascular
Date received: 1981-09-18
Decision date: 1981-12-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkton, MD, 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 Terumo Medical Corp.

view all

K111606 — PINNACLE PRECISION ACCESS SYSTEM2011-10-03
K111556 — GLIDECROSS SUPPORT CATHETER2011-07-29
K110540 — TERUMO SUPPORT CATHETER2011-05-13
K102008 — GLIDESHEATH2010-07-21
K091329 — PINNACLE DESTINATION PERIPHERAL GUIDING SHEATH2009-05-29

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