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FDA 510(k)

CARDIO METRIC CUSTOM PERFUSION TUBING

K-Number: K841959 · 1984-10-19

ApplicantSterile Design, Inc.
Decision Date1984-10-19
Product CodeDWE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIO METRIC CUSTOM PERFUSION TUBING is the device name listed in this FDA 510(k) record. The listed applicant is Sterile Design, Inc.. It received FDA 510(k) clearance on 1984-10-19 under 510(k) number K841959. 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 CARDIO METRIC CUSTOM PERFUSION TUBING?

CARDIO METRIC CUSTOM PERFUSION TUBING is a medical device that received FDA 510(k) clearance on 1984-10-19. The listed applicant is Sterile Design, Inc.. The 510(k) number is K841959.

When did CARDIO METRIC CUSTOM PERFUSION TUBING receive FDA 510(k) clearance?

CARDIO METRIC CUSTOM PERFUSION TUBING received FDA 510(k) clearance on 1984-10-19, under 510(k) number K841959.

Who is the listed applicant for CARDIO METRIC CUSTOM PERFUSION TUBING?

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

What is the FDA product code for CARDIO METRIC CUSTOM PERFUSION TUBING?

The FDA product code for CARDIO METRIC CUSTOM PERFUSION TUBING is DWE.

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Other records listing Sterile Design, 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.

K934688STERILE DESIGNK841960CARDIO METRICS INVASIVE PRESSURE MONITK842356CUSTOM STERILE PROCEDURE KITSK841958CARDIO METRICS CARDIOTOMY RESERVOIRK842351STERILE DESIGN-CUSTOM STERILE IV KITK834239SDI C-FLEX STERILE LIGHT HANDLE

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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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