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FDA 510(k)

CATHETER PLUG/PROTECTOR

K-Number: K896806 · 1990-02-26

ApplicantWestmark, Sterile Packing Systems, Inc. (Sps)
Decision Date1990-02-26
Product CodeKNY
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

CATHETER PLUG/PROTECTOR is the device name listed in this FDA 510(k) record. The listed applicant is Westmark, Sterile Packing Systems, Inc. (Sps). It received FDA 510(k) clearance on 1990-02-26 under 510(k) number K896806. The device is classified under product code KNY. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CATHETER PLUG/PROTECTOR?

CATHETER PLUG/PROTECTOR is a medical device that received FDA 510(k) clearance on 1990-02-26. The listed applicant is Westmark, Sterile Packing Systems, Inc. (Sps). The 510(k) number is K896806.

When did CATHETER PLUG/PROTECTOR receive FDA 510(k) clearance?

CATHETER PLUG/PROTECTOR received FDA 510(k) clearance on 1990-02-26, under 510(k) number K896806.

Who is the listed applicant for CATHETER PLUG/PROTECTOR?

The FDA 510(k) record lists Westmark, Sterile Packing Systems, Inc. (Sps) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CATHETER PLUG/PROTECTOR?

The FDA product code for CATHETER PLUG/PROTECTOR is KNY.

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Other records listing Westmark, Sterile Packing Systems, Inc. (Sps) 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.

K896800IRRIGATION TRAYK896799PARACERVICAL/PUDENDAL TRAYSK896559INFANT FEEDING TUBEK896794SPECIMEN CONTAINERK896798TRACHEOSTOMY TRAYK896797SUCTION CATHETER KIT

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Related Devices (Code: KNY)

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.

K260919Transurethral Catheter Safety Valve (TUCSV) (80050)Class Medical , Ltd.K182144Bi-Flex EvoPromepla SamK162356Vesair Cystoscopic SheathSolace TherapeuticsK131803GUARDIAN URETHRAL SHEATHSolace TherapeuticsK123170VARI-PASS VARIABLE LENGTH ACCESS SHEATHOlympus Surgical Technologies AmericaK120160ROCAMED ROCAUS PLATINUMPromepla Sam

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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