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

FDA 510(k)

Aspiration Catheter (2189)

K-Number: K241874 · 2024-09-24

ApplicantHobbs Medical, Inc.
Decision Date2024-09-24
Product CodeOCX
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

Aspiration Catheter (2189) is a medical device manufactured by Hobbs Medical, Inc.. It received FDA 510(k) clearance on 2024-09-24 under approval number K241874. The device is classified under product code OCX. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aspiration Catheter (2189)?

Aspiration Catheter (2189) is a medical device that received FDA 510(k) clearance on 2024-09-24. It is manufactured by Hobbs Medical, Inc.. The 510(k) number is K241874.

When was Aspiration Catheter (2189) approved by the FDA?

Aspiration Catheter (2189) received FDA 510(k) clearance on 2024-09-24, under approval number K241874.

What company makes Aspiration Catheter (2189)?

Aspiration Catheter (2189) is manufactured by Hobbs Medical, Inc..

What is the FDA product code for Aspiration Catheter (2189)?

The FDA product code for Aspiration Catheter (2189) is OCX.

Related Clinical Trials

NCT07216170 REVascularization In Large VEssel Occlusion for Acute Ischemic Stroke NOT_YET_RECRUITING NCT07274527 Amnioinfusion's Protective Effects on Respiratory and Longitudinal Pediatric Outcomes After Intrapartum Thick Meconium Exposure RECRUITING NCT07571954 Efficacy and Safety Evaluation of iNstroke 5F Aspiration Catheter for Thrombectomy NOT_YET_RECRUITING NCT06615713 CLinical Evaluation of Aspiration for Removal ANd ClearancE of Stones COMPLETED

Other Devices by Hobbs Medical, Inc.

K182927Pulmonary Cytology Brush

Related Devices (Code: OCX)

K161167Seal Single-Use Biopsy ValveEndochoice, Inc. K152278ENDOFLOW II - Irrigation, Warming and Suction SystemPromepla Sam K182444ERBEFLO Olympus Scope Port ConnectorErbe USA, Inc. K182275Seal Single Use Biopsy ValveBoston Scientific Corporation K181509Endorate Valve SetsSmartdata Suzhou Co., Ltd. K173758Disposable Biopsy ValveZhejiang Chuangxiang Medical Technology Co., Ltd.

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.

↑