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FDA 510(k)

Millipede 088 Access Catheter

K-Number: K214048 · 2022-09-20

ApplicantPerfuze, Ltd.
Decision Date2022-09-20
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Millipede 088 Access Catheter is the device name listed in this FDA 510(k) record. The listed applicant is Perfuze, Ltd.. It received FDA 510(k) clearance on 2022-09-20 under 510(k) number K214048. The device is classified under product code QJP. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Millipede 088 Access Catheter?

Millipede 088 Access Catheter is a medical device that received FDA 510(k) clearance on 2022-09-20. The listed applicant is Perfuze, Ltd.. The 510(k) number is K214048.

When did Millipede 088 Access Catheter receive FDA 510(k) clearance?

Millipede 088 Access Catheter received FDA 510(k) clearance on 2022-09-20, under 510(k) number K214048.

Who is the listed applicant for Millipede 088 Access Catheter?

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

What is the FDA product code for Millipede 088 Access Catheter?

The FDA product code for Millipede 088 Access Catheter is QJP.

Related Clinical Trials

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.

NCT05714501Millipede AspiRation for Revascularization in Stroke (MARRS) StudyCOMPLETED

Other records listing Perfuze, Ltd. 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.

K262399Millipede SystemK253901Millipede88 Access CatheterK253590Millipede SystemK252392Millipede70 Aspiration Catheter; Perfuze Aspiration Tube SetK250012Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube SetK240711Zipline Access Catheter

View all 11 devices →

Related Devices (Code: QJP)

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.

K260199SLIM MicrocatheterBalt USA, LLCK253901Millipede88 Access CatheterPerfuze, Ltd.K261889Trevo Trak 21 MicrocatheterStryker NeurovascularK261808ISAAC Neurovascular Navigation CatheterMicrovention Inc. d/b/a Terumo NeuroK261549BOBBY Balloon Guide CatheterMicroVention, Inc., d/b/a Terumo NeuroK253359Zenith Distal Access Long SheathSuzhou Zenith Vascular SciTech Limited

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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