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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 a medical device manufactured by Perfuze, Ltd.. It received FDA 510(k) clearance on 2022-09-20 under approval 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. It is manufactured by Perfuze, Ltd.. The 510(k) number is K214048.

When was Millipede 088 Access Catheter approved by the FDA?

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

What company makes Millipede 088 Access Catheter?

Millipede 088 Access Catheter is manufactured by Perfuze, Ltd..

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

NCT07610681 Midline Catheter Study ACTIVE_NOT_RECRUITING NCT07585188 Neonatal Catheter Lock for Infection Prevention NOT_YET_RECRUITING NCT07512986 Simulation and Video Training for Phlebitis Recognition and Clinical Decision-Making in Nursing Students NOT_YET_RECRUITING NCT04498598 Structural Modification In Supraglottic Airway Device RECRUITING NCT02633124 Preventing Catheter-related Bacteremia When Administering Injectable Medications in Premature Infants. TERMINATED NCT07515040 Comparative Study on the Safety and Efficacy of Using AccuSafe Transseptal Guidewire Versus Traditional Transseptal Needle for Transseptal Puncture in non-or Free- Guidance RECRUITING

Other Devices by Perfuze, Ltd.

K233648Millipede 088 Access Catheter K232524Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set K231802Millipede 088 Access Catheter K240711Zipline Access Catheter K242504Millipede 088 Access Catheter; Millipede 070 Aspiration Catheter; Perfuze Aspiration Tube Set K252392Millipede70 Aspiration Catheter; Perfuze Aspiration Tube Set

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Related Devices (Code: QJP)

K203043Route 92 Medical 070 Access SystemRoute 92 Medical, Inc. K201682RIST Radial Access CatheterRist Neurovascular, Inc. K201518Route 92 Medical 088 Access SystemRoute 92 Medical K201076Anchor Dual Lumen Guidewire CatheterAqure Medical, Inc. K200910BOSS Balloon Guide CatheterMarblehead Medical K200417RIST Radial Access CatheterRist Neurovascular, 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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