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FDA 510(k)

10.5 FRENCH DILATOR, 15CM, W/LUER LOCK

K-Number: K841995 · 1984-07-02

ApplicantQuinton, Inc.
Decision Date1984-07-02
Product CodeDRE
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

10.5 FRENCH DILATOR, 15CM, W/LUER LOCK is the device name listed in this FDA 510(k) record. The listed applicant is Quinton, Inc.. It received FDA 510(k) clearance on 1984-07-02 under 510(k) number K841995. The device is classified under product code DRE. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 10.5 FRENCH DILATOR, 15CM, W/LUER LOCK?

10.5 FRENCH DILATOR, 15CM, W/LUER LOCK is a medical device that received FDA 510(k) clearance on 1984-07-02. The listed applicant is Quinton, Inc.. The 510(k) number is K841995.

When did 10.5 FRENCH DILATOR, 15CM, W/LUER LOCK receive FDA 510(k) clearance?

10.5 FRENCH DILATOR, 15CM, W/LUER LOCK received FDA 510(k) clearance on 1984-07-02, under 510(k) number K841995.

Who is the listed applicant for 10.5 FRENCH DILATOR, 15CM, W/LUER LOCK?

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 10.5 FRENCH DILATOR, 15CM, W/LUER LOCK?

The FDA product code for 10.5 FRENCH DILATOR, 15CM, W/LUER LOCK is DRE.

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Other records listing Quinton, Inc. as applicant

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Related Devices (Code: DRE)

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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