TYGON TUBING— 510(k) K803277

Name: FDA 510(k) clearance K803277
Creator: U.S. Food and Drug Administration
Published: 1981-01-13

Substantially Equivalent

Electromedics, Inc.

FDA 510(k) clearance K803277 for TYGON TUBING, Substantially Equivalent on 1981-01-13. Applicant: Electromedics, Inc.. Device class: 2.

Clearance details

Applicant: Electromedics, Inc.
Product code: Code DWE
Device class: Class 2
Regulation: 21 CFR 870.4390
Advisory panel: Cardiovascular
Date received: 1980-12-29
Decision date: 1981-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DWE

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K233702 — SMARxT Tubing and Connectors2024-08-08
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K142607 — AngioVac Circuit2014-12-11
K092486 — VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUIT2009-08-28
K080592 — HLM TUBING SET WITH BIOLINE COATING2008-09-11

More clearances from Electromedics, Inc.

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K934964 — ELECTROMEDICS TYMPANIC TEMPERATURE SENSOR1994-03-07
K933832 — ELECTROMEDICS HG (HYDROGEL) SERIES SKIN TEMPERATURE SENSOR1994-01-28
K934355 — ELECTROMEDICS BLOOD HEAT EXCHANGER1993-12-03
K930154 — EL2-SERIES BLOOD COLLECTION REERVOIR1993-07-01
K926250 — ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIR1993-02-19

Adverse events under product code DWE

product code DWE

Death: 9
Malfunction: 754
Total: 763

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K803277

K-number listed on FDA's recall record

Z-0785-2019 — RESERVOIR "Y" ADAPTER, (a) BT920 (b) BT926 Suction and Anticoagulation assemblies are indicated for use with an autotransfusion system between the suction tip and reservoir.Class II·Ongoing·Medtronic Perfusion Systems·20181127

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K803277.

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