FILTER, ARTERIAL BLOOD W/TUBING BYPASS— 510(k) K781707

Name: FDA 510(k) clearance K781707
Creator: U.S. Food and Drug Administration
Published: 1978-10-26

Substantially Equivalent

Surgikos, Inc.

FDA 510(k) clearance K781707 for FILTER, ARTERIAL BLOOD W/TUBING BYPASS, Substantially Equivalent on 1978-10-26. Applicant: Surgikos, Inc.. Device class: 2.

Clearance details

Applicant: Surgikos, Inc.
Product code: Code DTM
Device class: Class 2
Regulation: 21 CFR 870.4260
Advisory panel: Cardiovascular
Date received: 1978-10-10
Decision date: 1978-10-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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 Surgikos, Inc.

view all

K875107 — HEALTH CARE EYE PROTECTION1988-03-21
K874653 — STERILE SURGICAL SCRUB BRUSH1987-12-30
K861441 — NEUTRALON SURGICAL GLOVES1986-05-30
K852870 — BARRIER SURGICAL GOWN1985-07-23
K822535 — CIDEX*DIALYZER DISINFECTING SOLUTION1982-09-30

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