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FDA 510(k)

OPERATIVE CHOLANGIOGRAPHIC CATHETER

K-Number: K905738 · 1991-03-21

Decision Date1991-03-21
Product CodeFGE
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

OPERATIVE CHOLANGIOGRAPHIC CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Applied Vascular Devices, Inc.. It received FDA 510(k) clearance on 1991-03-21 under 510(k) number K905738. The device is classified under product code FGE. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OPERATIVE CHOLANGIOGRAPHIC CATHETER?

OPERATIVE CHOLANGIOGRAPHIC CATHETER is a medical device that received FDA 510(k) clearance on 1991-03-21. The listed applicant is Applied Vascular Devices, Inc.. The 510(k) number is K905738.

When did OPERATIVE CHOLANGIOGRAPHIC CATHETER receive FDA 510(k) clearance?

OPERATIVE CHOLANGIOGRAPHIC CATHETER received FDA 510(k) clearance on 1991-03-21, under 510(k) number K905738.

Who is the listed applicant for OPERATIVE CHOLANGIOGRAPHIC CATHETER?

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

What is the FDA product code for OPERATIVE CHOLANGIOGRAPHIC CATHETER?

The FDA product code for OPERATIVE CHOLANGIOGRAPHIC CATHETER is FGE.

Related Clinical Trials

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.

Other records listing Applied Vascular Devices, Inc. as applicant

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.

View all 21 devices →

Related Devices (Code: FGE)

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.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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