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FDA 510(k)

DUAL PURPOSE CATHETER

K-Number: K945994 · 1995-06-21

ApplicantUniversal Medical Products, Inc.
Decision Date1995-06-21
Product CodeBSY
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

DUAL PURPOSE CATHETER is the device name listed in this FDA 510(k) record. The listed applicant is Universal Medical Products, Inc.. It received FDA 510(k) clearance on 1995-06-21 under 510(k) number K945994. 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 CATHETER?

DUAL PURPOSE CATHETER is a medical device that received FDA 510(k) clearance on 1995-06-21. The listed applicant is Universal Medical Products, Inc.. The 510(k) number is K945994.

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

DUAL PURPOSE CATHETER received FDA 510(k) clearance on 1995-06-21, under 510(k) number K945994.

Who is the listed applicant for DUAL PURPOSE CATHETER?

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

What is the FDA product code for DUAL PURPOSE CATHETER?

The FDA product code for DUAL PURPOSE 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.K982945DUAL PURPOSE CLOSED CATHETERSpirit Medical Systems, Inc.K981910SUCTION CATHETERNi-Med, Inc.K972258HI-CARE CLOSED SUCTION SYSTEMMallinckrodt MedicalK973199AMSINO SUCTION CATHETERAmsino Intl., Inc.

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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