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FDA 510(k)

CAVITY DRAINAGE CATHETERIZATION SET, CS-01600

K-Number: K895516 · 1989-12-27

ApplicantArrow Intl., Inc.
Decision Date1989-12-27
Product CodeGBX
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

CAVITY DRAINAGE CATHETERIZATION SET, CS-01600 is the device name listed in this FDA 510(k) record. The listed applicant is Arrow Intl., Inc.. It received FDA 510(k) clearance on 1989-12-27 under 510(k) number K895516. The device is classified under product code GBX. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CAVITY DRAINAGE CATHETERIZATION SET, CS-01600?

CAVITY DRAINAGE CATHETERIZATION SET, CS-01600 is a medical device that received FDA 510(k) clearance on 1989-12-27. The listed applicant is Arrow Intl., Inc.. The 510(k) number is K895516.

When did CAVITY DRAINAGE CATHETERIZATION SET, CS-01600 receive FDA 510(k) clearance?

CAVITY DRAINAGE CATHETERIZATION SET, CS-01600 received FDA 510(k) clearance on 1989-12-27, under 510(k) number K895516.

Who is the listed applicant for CAVITY DRAINAGE CATHETERIZATION SET, CS-01600?

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

What is the FDA product code for CAVITY DRAINAGE CATHETERIZATION SET, CS-01600?

The FDA product code for CAVITY DRAINAGE CATHETERIZATION SET, CS-01600 is GBX.

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Related Devices (Code: GBX)

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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