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FDA 510(k)

SUCTION CATHETER KIT

K-Number: K896797 · 1990-02-16

ApplicantWestmark, Sterile Packing Systems, Inc. (Sps)
Decision Date1990-02-16
Product CodeBSY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

SUCTION CATHETER KIT 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 1990-02-16 under 510(k) number K896797. The device is classified under product code BSY. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SUCTION CATHETER KIT?

SUCTION CATHETER KIT is a medical device that received FDA 510(k) clearance on 1990-02-16. The listed applicant is Westmark, Sterile Packing Systems, Inc. (Sps). The 510(k) number is K896797.

When did SUCTION CATHETER KIT receive FDA 510(k) clearance?

SUCTION CATHETER KIT received FDA 510(k) clearance on 1990-02-16, under 510(k) number K896797.

Who is the listed applicant for SUCTION CATHETER KIT?

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 SUCTION CATHETER KIT?

The FDA product code for SUCTION CATHETER KIT is BSY.

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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 CONTAINERK896806CATHETER PLUG/PROTECTORK896798TRACHEOSTOMY TRAY

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Related Devices (Code: BSY)

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.

K031997MALLINCKRODT DAR TY-CARE / TY-CARE EXEL CLOSED SUCTION SYSTEMMallinckrodt Dar S.R.L.K992902AMBU HAND POWER SUCTION PUMPAmbu, Inc.K982945DUAL PURPOSE CLOSED CATHETERSpirit Medical Systems, Inc.K981910SUCTION CATHETERNi-Med, Inc.K972258HI-CARE CLOSED SUCTION SYSTEMMallinckrodt MedicalK973199AMSINO SUCTION CATHETERAmsino Intl., 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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