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FDA 510(k)

WILTEK NASAL BILIARY DRAINAGE SET

K-Number: K894870 · 1989-12-21

ApplicantWiltek Medical, Inc.
Decision Date1989-12-21
Product CodeBSS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

WILTEK NASAL BILIARY DRAINAGE SET is the device name listed in this FDA 510(k) record. The listed applicant is Wiltek Medical, Inc.. It received FDA 510(k) clearance on 1989-12-21 under 510(k) number K894870. The device is classified under product code BSS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the WILTEK NASAL BILIARY DRAINAGE SET?

WILTEK NASAL BILIARY DRAINAGE SET is a medical device that received FDA 510(k) clearance on 1989-12-21. The listed applicant is Wiltek Medical, Inc.. The 510(k) number is K894870.

When did WILTEK NASAL BILIARY DRAINAGE SET receive FDA 510(k) clearance?

WILTEK NASAL BILIARY DRAINAGE SET received FDA 510(k) clearance on 1989-12-21, under 510(k) number K894870.

Who is the listed applicant for WILTEK NASAL BILIARY DRAINAGE SET?

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

What is the FDA product code for WILTEK NASAL BILIARY DRAINAGE SET?

The FDA product code for WILTEK NASAL BILIARY DRAINAGE SET is BSS.

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Other records listing Wiltek Medical, 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.

K990231WILTEK HOT BIOPSY FORCEPSK922989WILTEK IRRIGAITON/ASPIRATION TUBE SETK930419WILTEK BIOPSY FORCEPSK914881WILTEK LAPAROSCOPIC CHOLANGIOGRAPHY CATHETERK914882WILTEK BALLOON CHOLANGIOGRAPHY CATHETERK914131WILTEK ELECTROCAUTERY ADAPTOR

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Related Devices (Code: BSS)

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.

K051480ENTERAL FEEDING TUBEBiosearch Medical Products, Inc.K984629MOSS TUBES, INC. NASAL TUBE - MARK IVMoss Tubes, Inc.K961711ASPISAFE GASTRIC TUBEB.Braun Medical, Inc.K933596GASTRIC, CATHETER, IRRIGATION & ASPIRATIONPolamedco, Inc.K930510RADIUS ENTERAL FEEDING TUBERadius Intl., Inc.K935688AN-10S ANDERSEN TUBE WITH STYLETH.W. Andersen Products, 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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