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FDA 510(k)

CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN

K-Number: K853383 · 1985-12-03

ApplicantWebster Laboratories, Inc.
Decision Date1985-12-03
Product CodeDYG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN is the device name listed in this FDA 510(k) record. The listed applicant is Webster Laboratories, Inc.. It received FDA 510(k) clearance on 1985-12-03 under 510(k) number K853383. The device is classified under product code DYG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN?

CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN is a medical device that received FDA 510(k) clearance on 1985-12-03. The listed applicant is Webster Laboratories, Inc.. The 510(k) number is K853383.

When did CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN receive FDA 510(k) clearance?

CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN received FDA 510(k) clearance on 1985-12-03, under 510(k) number K853383.

Who is the listed applicant for CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN?

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

What is the FDA product code for CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN?

The FDA product code for CARDIOVASCULAR, THERMODILUTION, FLOW, CORONARY SIN is DYG.

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Other records listing Webster Laboratories, 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.

K841802ELECTRODE CATHETER, ORTHOGONAL TYPEK834602SWITCHING UNIT ELECTRODE CATHETERK823361SWITCHING UNIT ELECTRODE CATHETERSK813271TEMPERATURE PROBES

Related Devices (Code: DYG)

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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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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