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FDA 510(k)

TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE

K-Number: K894721 · 1989-10-20

ApplicantThe Traumafuse Co.
Decision Date1989-10-20
Product CodeDWE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE is the device name listed in this FDA 510(k) record. The listed applicant is The Traumafuse Co.. It received FDA 510(k) clearance on 1989-10-20 under 510(k) number K894721. 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 TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE?

TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE is a medical device that received FDA 510(k) clearance on 1989-10-20. The listed applicant is The Traumafuse Co.. The 510(k) number is K894721.

When did TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE receive FDA 510(k) clearance?

TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE received FDA 510(k) clearance on 1989-10-20, under 510(k) number K894721.

Who is the listed applicant for TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE?

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

What is the FDA product code for TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE?

The FDA product code for TRAUMAFUSE PERFUSION PRESSURE RELIEF VALVE is DWE.

Related Clinical Trials

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.

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Other records listing The Traumafuse Co. 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.

K895162TRAUMAFUSE TRACH SHIELDK895132CONNELL-STEPHENS ENDO ANESS TUBEK890077TRAUMAFUSE RAPID INFUSION DEVICE

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

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

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