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FDA 510(k)

PROWLER SELECT PLUS; PROWLER EX

K-Number: K210838 · 2021-08-25

ApplicantMedos International SARL
Decision Date2021-08-25
Product CodeKRA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PROWLER SELECT PLUS; PROWLER EX is the device name listed in this FDA 510(k) record. The listed applicant is Medos International SARL. It received FDA 510(k) clearance on 2021-08-25 under 510(k) number K210838. 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 PROWLER SELECT PLUS; PROWLER EX?

PROWLER SELECT PLUS; PROWLER EX is a medical device that received FDA 510(k) clearance on 2021-08-25. The listed applicant is Medos International SARL. The 510(k) number is K210838.

When did PROWLER SELECT PLUS; PROWLER EX receive FDA 510(k) clearance?

PROWLER SELECT PLUS; PROWLER EX received FDA 510(k) clearance on 2021-08-25, under 510(k) number K210838.

Who is the listed applicant for PROWLER SELECT PLUS; PROWLER EX?

The FDA 510(k) record lists Medos International SARL as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PROWLER SELECT PLUS; PROWLER EX?

The FDA product code for PROWLER SELECT PLUS; PROWLER EX is KRA.

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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

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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