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FDA 510(k)

SALINE/ CONTRAST MEDIA INFUSION CATHETER

K-Number: K063611 · 2007-05-23

ApplicantUtah Medical Products, Inc.
Decision Date2007-05-23
Product CodeLKF
Advisory CommitteeOB
DecisionSubstantially Equivalent

Device Summary

SALINE/ CONTRAST MEDIA INFUSION CATHETER 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 2007-05-23 under 510(k) number K063611. The device is classified under product code LKF. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SALINE/ CONTRAST MEDIA INFUSION CATHETER?

SALINE/ CONTRAST MEDIA INFUSION CATHETER is a medical device that received FDA 510(k) clearance on 2007-05-23. The listed applicant is Utah Medical Products, Inc.. The 510(k) number is K063611.

When did SALINE/ CONTRAST MEDIA INFUSION CATHETER receive FDA 510(k) clearance?

SALINE/ CONTRAST MEDIA INFUSION CATHETER received FDA 510(k) clearance on 2007-05-23, under 510(k) number K063611.

Who is the listed applicant for SALINE/ CONTRAST MEDIA INFUSION CATHETER?

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 SALINE/ CONTRAST MEDIA INFUSION CATHETER?

The FDA product code for SALINE/ CONTRAST MEDIA INFUSION CATHETER is LKF.

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Other records listing Utah Medical Products, Inc. as applicant

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Related Devices (Code: LKF)

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.

K253403FemVue® Controlled Saline-Air Device (FSA-300)Femasys, Inc.K252260RELIEEV HSG Catheter (HSG7FA1)Li Medical Corporation , Ltd.K242002FemVue MINI Saline-Air DeviceFemasys, Inc.K240364RELIEEV Uterine Manipulator Injector (CUMI 5.0)Li Medical Corporation , Ltd.K241693FemChec Controlled Saline-Air Device (FCD-250)Femasys, Inc.K222798Rejoni Intrauterine CatheterRejoni, 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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