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FDA 510(k)

SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F

K-Number: K180994 · 2019-07-09

Decision Date2019-07-09
Product CodeKMK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F is the device name listed in this FDA 510(k) record. The listed applicant is Interrad Medical, Inc.. It received FDA 510(k) clearance on 2019-07-09 under 510(k) number K180994. The device is classified under product code KMK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F?

SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F is a medical device that received FDA 510(k) clearance on 2019-07-09. The listed applicant is Interrad Medical, Inc.. The 510(k) number is K180994.

When did SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F receive FDA 510(k) clearance?

SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F received FDA 510(k) clearance on 2019-07-09, under 510(k) number K180994.

Who is the listed applicant for SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F?

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

What is the FDA product code for SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F?

The FDA product code for SecurAcath 10F, SecurAcath 12F, SecurAcath 5F, SecurAcath 5F, SecurAcath 6F, SecurAcath 7F/SecurAcath 8F is KMK.

Other records listing Interrad Medical, 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.

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.