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FDA 510(k)

INTRAN 500

K-Number: K961424 · 1996-07-10

ApplicantUtah Medical Products, Inc.
Decision Date1996-07-10
Product CodeHFN
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

INTRAN 500 is the device name listed in this FDA 510(k) record. The listed applicant is Utah Medical Products, Inc.. It received FDA 510(k) clearance on 1996-07-10 under 510(k) number K961424. The device is classified under product code HFN. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTRAN 500?

INTRAN 500 is a medical device that received FDA 510(k) clearance on 1996-07-10. The listed applicant is Utah Medical Products, Inc.. The 510(k) number is K961424.

When did INTRAN 500 receive FDA 510(k) clearance?

INTRAN 500 received FDA 510(k) clearance on 1996-07-10, under 510(k) number K961424.

Who is the listed applicant for INTRAN 500?

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

What is the FDA product code for INTRAN 500?

The FDA product code for INTRAN 500 is HFN.

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Other records listing Utah Medical Products, Inc. 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.

K123310FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+)K101535BT-CATHK063611SALINE/ CONTRAST MEDIA INFUSION CATHETERK001874PERIPHERALLY INSERTED CENTRAL CATHETERK000974FOWLER ENDOCURETTE, MODEL CUR-XXXK965245TBD

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Related Devices (Code: HFN)

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.

K250897Koala Intrauterine Pressure Catheter (IPC-5000E)Clinical Innovations, LLCK974389KOALA INTRAUTERINE PRESSURE CATHETER, KOALA EXTERNAL INTRAUTERINE PRESSURE CATHETERClinical Innovations, Inc.K973746PRE-FILLED SYRINGE FOR KOALA IUPClinical Innovations, Inc.K954955STORC INTRAUTERINE PRESSURE CATHETERClinical Innovations, Inc.K955443INTRAN PLUSUtah Medical Products, Inc.K920375DISPOSABLE INTRAUTERINE PRESSURE TRANSDUCERTelos Medical Corp.

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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