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FDA 510(k)

DISPOSABLE ANGIOGRAPHY NEEDLES

K-Number: K890209 · 1989-05-19

ApplicantE-Z-Em, Inc.
Decision Date1989-05-19
Product CodeDRC
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

DISPOSABLE ANGIOGRAPHY NEEDLES is the device name listed in this FDA 510(k) record. The listed applicant is E-Z-Em, Inc.. It received FDA 510(k) clearance on 1989-05-19 under 510(k) number K890209. The device is classified under product code DRC. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DISPOSABLE ANGIOGRAPHY NEEDLES?

DISPOSABLE ANGIOGRAPHY NEEDLES is a medical device that received FDA 510(k) clearance on 1989-05-19. The listed applicant is E-Z-Em, Inc.. The 510(k) number is K890209.

When did DISPOSABLE ANGIOGRAPHY NEEDLES receive FDA 510(k) clearance?

DISPOSABLE ANGIOGRAPHY NEEDLES received FDA 510(k) clearance on 1989-05-19, under 510(k) number K890209.

Who is the listed applicant for DISPOSABLE ANGIOGRAPHY NEEDLES?

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

What is the FDA product code for DISPOSABLE ANGIOGRAPHY NEEDLES?

The FDA product code for DISPOSABLE ANGIOGRAPHY NEEDLES is DRC.

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Other records listing E-Z-Em, Inc. as applicant

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Related Devices (Code: DRC)

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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