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FDA 510(k)

MMS Guide Catheter

K-Number: K152625 · 2016-03-09

ApplicantMicro Medical Solutions, Inc.
Decision Date2016-03-09
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MMS Guide Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Micro Medical Solutions, Inc.. It received FDA 510(k) clearance on 2016-03-09 under 510(k) number K152625. The device is classified under product code KRA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MMS Guide Catheter?

MMS Guide Catheter is a medical device that received FDA 510(k) clearance on 2016-03-09. The listed applicant is Micro Medical Solutions, Inc.. The 510(k) number is K152625.

When did MMS Guide Catheter receive FDA 510(k) clearance?

MMS Guide Catheter received FDA 510(k) clearance on 2016-03-09, under 510(k) number K152625.

Who is the listed applicant for MMS Guide Catheter?

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

What is the FDA product code for MMS Guide Catheter?

The FDA product code for MMS Guide Catheter is KRA.

Other records listing Micro Medical Solutions, 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.

K152934MMS PTA Balloon Catheter

Related Devices (Code: KRA)

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.

K261610Verge™ MicrocatheterInstylla, Inc.K260771TruSelect™ 2.6 MicrocatheterBoston Scientific CorporationK250794InVera Infusion DeviceInvera MedicalK243534Micro CatheterSuzhou Zenith Vascular SciTech LimitedK231821XO Cath Microcatheter (E20-090-S, E20-110-S, E20-130-S, E20-150-S, E20-175-S, E20-220-S, E20-090-B, E20-110-B, E20-130-B, E20-150-B, E20-175-B, E20-220-B, E26-090-S, E26-110-S, E26-130-S, E26-150-S, E26-175-S, E26-220-S, E26-090-B, E26-110-B, E26-130-B, E26-150-B, E26-175-B, E26-220-B,)Transit Scientific, LLCK231279Peregrine System Infusion Catheter 4-7 mm, Peregrine System Infusion Catheter 3-4 mmAblative Solutions, 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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