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FDA 510(k)

STERI-CATH(TM)

K-Number: K902383 · 1990-07-12

ApplicantConcord/Portex
Decision Date1990-07-12
Product CodeBSY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

STERI-CATH(TM) is the device name listed in this FDA 510(k) record. The listed applicant is Concord/Portex. It received FDA 510(k) clearance on 1990-07-12 under 510(k) number K902383. 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 STERI-CATH(TM)?

STERI-CATH(TM) is a medical device that received FDA 510(k) clearance on 1990-07-12. The listed applicant is Concord/Portex. The 510(k) number is K902383.

When did STERI-CATH(TM) receive FDA 510(k) clearance?

STERI-CATH(TM) received FDA 510(k) clearance on 1990-07-12, under 510(k) number K902383.

Who is the listed applicant for STERI-CATH(TM)?

The FDA 510(k) record lists Concord/Portex as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for STERI-CATH(TM)?

The FDA product code for STERI-CATH(TM) is BSY.

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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.

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Other records listing Concord/Portex 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.

K923559STERI-CATH MDIK930218SUBCUTANEOUS TUNNELING NEEDLE AND HANDLESK924541EPIDURAL MINIPACKK930286DRI-VENDT/PROVENT/ACCUVENT ARTERIAL BLOOD GAS KITSK923127NEEDLE-PRO CARTRIDGEK923910HEAT MOISTURE CONDENSER

View all 23 devices →

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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