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FDA 510(k)

8F Modified Sheath System

K-Number: K240529 · 2024-10-02

ApplicantRoute 92 Medical, Inc.
Decision Date2024-10-02
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

8F Modified Sheath System is the device name listed in this FDA 510(k) record. The listed applicant is Route 92 Medical, Inc.. It received FDA 510(k) clearance on 2024-10-02 under 510(k) number K240529. 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 8F Modified Sheath System?

8F Modified Sheath System is a medical device that received FDA 510(k) clearance on 2024-10-02. The listed applicant is Route 92 Medical, Inc.. The 510(k) number is K240529.

When did 8F Modified Sheath System receive FDA 510(k) clearance?

8F Modified Sheath System received FDA 510(k) clearance on 2024-10-02, under 510(k) number K240529.

Who is the listed applicant for 8F Modified Sheath System?

The FDA 510(k) record lists Route 92 Medical, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 8F Modified Sheath System?

The FDA product code for 8F Modified Sheath System is QJP.

Other records listing Route 92 Medical, 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.

K243601Route 92 Medical HiPoint Reperfusion System and Aspiration Tubing SetK233329Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing SetK231583Route 92 Medical Full Length 054 Access SystemK223530Route 92 Medical Full Length 070 Reperfusion System and Aspiration Tubing SetK222743Route 92 Medical Full Length 070 Access SystemK210635Route 92 Medical Full Length 088 Access System

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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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