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FDA 510(k)

DUAL PURPOSE CLOSED CATHETER

K-Number: K982945 · 1998-09-22

ApplicantSpirit Medical Systems, Inc.
Decision Date1998-09-22
Product CodeBSY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DUAL PURPOSE CLOSED CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Spirit Medical Systems, Inc.. It received FDA 510(k) clearance on 1998-09-22 under 510(k) number K982945. 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 DUAL PURPOSE CLOSED CATHETER?

DUAL PURPOSE CLOSED CATHETER is a medical device that received FDA 510(k) clearance on 1998-09-22. The listed applicant is Spirit Medical Systems, Inc.. The 510(k) number is K982945.

When did DUAL PURPOSE CLOSED CATHETER receive FDA 510(k) clearance?

DUAL PURPOSE CLOSED CATHETER received FDA 510(k) clearance on 1998-09-22, under 510(k) number K982945.

Who is the listed applicant for DUAL PURPOSE CLOSED CATHETER?

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

What is the FDA product code for DUAL PURPOSE CLOSED CATHETER?

The FDA product code for DUAL PURPOSE CLOSED CATHETER is BSY.

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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.K981910SUCTION CATHETERNi-Med, Inc.K972258HI-CARE CLOSED SUCTION SYSTEMMallinckrodt MedicalK973199AMSINO SUCTION CATHETERAmsino Intl., Inc.K961707TRACH-EZE CLOSED VENTILATION SUCTION SYSTEMSorenson Critical Care

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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