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FDA 510(k)

REPAIR KIT QUINTON TRIPLE LUMEN RIGHT ATRIAL CATHE

K-Number: K853860 · 1985-10-18

ApplicantQuinton, Inc.
Decision Date1985-10-18
Product CodeDQY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

REPAIR KIT QUINTON TRIPLE LUMEN RIGHT ATRIAL CATHE is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1985-10-18 under 510(k) number K853860. The device is classified under product code DQY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the REPAIR KIT QUINTON TRIPLE LUMEN RIGHT ATRIAL CATHE?

REPAIR KIT QUINTON TRIPLE LUMEN RIGHT ATRIAL CATHE is a medical device that received FDA 510(k) clearance on 1985-10-18. The listed applicant is Quinton, Inc.. The 510(k) number is K853860.

When did REPAIR KIT QUINTON TRIPLE LUMEN RIGHT ATRIAL CATHE receive FDA 510(k) clearance?

REPAIR KIT QUINTON TRIPLE LUMEN RIGHT ATRIAL CATHE received FDA 510(k) clearance on 1985-10-18, under 510(k) number K853860.

Who is the listed applicant for REPAIR KIT QUINTON TRIPLE LUMEN RIGHT ATRIAL CATHE?

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

What is the FDA product code for REPAIR KIT QUINTON TRIPLE LUMEN RIGHT ATRIAL CATHE?

The FDA product code for REPAIR KIT QUINTON TRIPLE LUMEN RIGHT ATRIAL CATHE is DQY.

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Other records listing Quinton, Inc. as applicant

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Related Devices (Code: DQY)

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

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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