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FDA 510(k)

Bullfrog Micro-Infusion Device

K-Number: K153501 · 2016-04-15

ApplicantMercator Medsystems, Inc.
Decision Date2016-04-15
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Bullfrog Micro-Infusion Device is the device name listed in this FDA 510(k) record. The listed applicant is Mercator Medsystems, Inc.. It received FDA 510(k) clearance on 2016-04-15 under 510(k) number K153501. 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 Bullfrog Micro-Infusion Device?

Bullfrog Micro-Infusion Device is a medical device that received FDA 510(k) clearance on 2016-04-15. The listed applicant is Mercator Medsystems, Inc.. The 510(k) number is K153501.

When did Bullfrog Micro-Infusion Device receive FDA 510(k) clearance?

Bullfrog Micro-Infusion Device received FDA 510(k) clearance on 2016-04-15, under 510(k) number K153501.

Who is the listed applicant for Bullfrog Micro-Infusion Device?

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

What is the FDA product code for Bullfrog Micro-Infusion Device?

The FDA product code for Bullfrog Micro-Infusion Device is KRA.

Other records listing Mercator Medsystems, 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.

K210339Bullfrog Micro-Infusion DeviceK161402Bullfrog Micro-Infusion Device

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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