Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set

K-Number: K233329 · 2024-04-23

ApplicantRoute 92 Medical, Inc.
Decision Date2024-04-23
Product CodeNRY
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set 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 2024-04-23 under 510(k) number K233329. The device is classified under product code NRY. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set?

Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set is a medical device that received FDA 510(k) clearance on 2024-04-23. The listed applicant is Route 92 Medical, Inc.. The 510(k) number is K233329.

When did Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set receive FDA 510(k) clearance?

Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set received FDA 510(k) clearance on 2024-04-23, under 510(k) number K233329.

Who is the listed applicant for Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set?

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 Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set?

The FDA product code for Route 92 Medical Full Length 054 Reperfusion System and Aspiration Tubing Set is NRY.

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.

NCT06391697Magnetic Bead Tracking System and eOPRA Implant System With Bionic Prosthesis for Transtibial AmputeesACTIVE_NOT_RECRUITINGNCT07644104Efficacy and Safety of the Visual Bronchial Blocker for Lung Isolation SurgeryNOT_YET_RECRUITING

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 SetK2405298F Modified Sheath SystemK231583Route 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

View all 14 devices →

Related Devices (Code: NRY)

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.

K262398CEREGLIDE 57 Intermediate Catheter; Cerenovus Aspiration Tubing setCERENOVUS, Inc.K262399Millipede SystemPerfuze, Ltd.K262391APRO 35 Swift Catheter and Alembic Aspiration TubingAlembic, LLCK260002Socrates Aspiration System (Socrates 70 Aspiration Catheter)Scientia Vascular, Inc.K250690Penumbra System (Thunderbolt Aspiration Tubing)Penumbra, Inc.K252707Zenith Aspiration Catheter; Disposable Aspiration Tubing SetSuzhou 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.

↑