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FDA 510(k)

TYGON TUBING

K-Number: K803277 · 1981-01-13

ApplicantElectromedics, Inc.
Decision Date1981-01-13
Product CodeDWE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TYGON TUBING is the device name listed in this FDA 510(k) record. The listed applicant is Electromedics, Inc.. It received FDA 510(k) clearance on 1981-01-13 under 510(k) number K803277. The device is classified under product code DWE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TYGON TUBING?

TYGON TUBING is a medical device that received FDA 510(k) clearance on 1981-01-13. The listed applicant is Electromedics, Inc.. The 510(k) number is K803277.

When did TYGON TUBING receive FDA 510(k) clearance?

TYGON TUBING received FDA 510(k) clearance on 1981-01-13, under 510(k) number K803277.

Who is the listed applicant for TYGON TUBING?

The FDA 510(k) record lists Electromedics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TYGON TUBING?

The FDA product code for TYGON TUBING is DWE.

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Other records listing Electromedics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K934964ELECTROMEDICS TYMPANIC TEMPERATURE SENSORK933832ELECTROMEDICS HG (HYDROGEL) SERIES SKIN TEMPERATURE SENSORK934355ELECTROMEDICS BLOOD HEAT EXCHANGERK930154EL2-SERIES BLOOD COLLECTION REERVOIRK926250ELECTROMEDICS EL-SERIES CARDIOTOMY RESERVOIRK925412ELECTROMEDICS TISSUE TRAP/ #TT280

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Related Devices (Code: DWE)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K233702SMARxT Tubing and ConnectorsLivaNova USA, Inc.K092486VORTEX MEDICAL ANGIOVAC CARDIOPULMONARY BYPASS CIRCUITVortex Medical, Inc.K080592HLM TUBING SET WITH BIOLINE COATINGMaquet Cardiopulmonary, AGK053025JOSTRA HLM TUBING SETMaquet Cardiopulmonary, AGK022857PUMP TUBING WITH X-COATINGTerumo Cardiovascular Systems CorporationK013578PUMP TUBINGTerumo Cardiovascular Systems Corp.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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