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FDA 510(k)

DIRECTABLE COAXIAL CATHETER SET

K-Number: K894716 · 1989-08-23

ApplicantCook Ob/Gyn
Decision Date1989-08-23
Product CodeGCJ
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

DIRECTABLE COAXIAL CATHETER SET is the device name listed in this FDA 510(k) record. The listed applicant is Cook Ob/Gyn. It received FDA 510(k) clearance on 1989-08-23 under 510(k) number K894716. The device is classified under product code GCJ. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIRECTABLE COAXIAL CATHETER SET?

DIRECTABLE COAXIAL CATHETER SET is a medical device that received FDA 510(k) clearance on 1989-08-23. The listed applicant is Cook Ob/Gyn. The 510(k) number is K894716.

When did DIRECTABLE COAXIAL CATHETER SET receive FDA 510(k) clearance?

DIRECTABLE COAXIAL CATHETER SET received FDA 510(k) clearance on 1989-08-23, under 510(k) number K894716.

Who is the listed applicant for DIRECTABLE COAXIAL CATHETER SET?

The FDA 510(k) record lists Cook Ob/Gyn as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIRECTABLE COAXIAL CATHETER SET?

The FDA product code for DIRECTABLE COAXIAL CATHETER SET is GCJ.

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Other records listing Cook Ob/Gyn as applicant

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Related Devices (Code: GCJ)

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.

K262397CuratOR EX2742Eizo CorporationK260884UNIDRIVE Select SystemKarl Storz SE & CO. KGK260972OEV-271MUH LCD Monitor;OEV-321MUH LCD Monitor;OEV-431MUH LCD MonitorSony CorporationK261139VereSee (VER150, VER200, VER151, VER201, VER200C, and VER-100-103)Freyja Healthcare, LLCK253541EZ-Close™ (EZ Close Port Site Closing Device, EZ Close MAX Port Site Closing Device, EZ Close II Port Site Closing Device)Medical ImpactK261614LED LCD Monitor (OEV-271H)Lg Electronics.Inc

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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