Benchmark BMX96 Access System
K-Number: K213390 · 2022-08-18
ApplicantPenumbra, Inc.
Decision Date2022-08-18
Product CodeQJP
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
Benchmark BMX96 Access System is a medical device manufactured by Penumbra, Inc.. It received FDA 510(k) clearance on 2022-08-18 under approval number K213390. 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 Benchmark BMX96 Access System?
Benchmark BMX96 Access System is a medical device that received FDA 510(k) clearance on 2022-08-18. It is manufactured by Penumbra, Inc.. The 510(k) number is K213390.
When was Benchmark BMX96 Access System approved by the FDA?
Benchmark BMX96 Access System received FDA 510(k) clearance on 2022-08-18, under approval number K213390.
What company makes Benchmark BMX96 Access System?
Benchmark BMX96 Access System is manufactured by Penumbra, Inc..
What is the FDA product code for Benchmark BMX96 Access System?
The FDA product code for Benchmark BMX96 Access System is QJP.
Related Clinical Trials
NCT07430293
Hybrid Closed-Loop Insulin Delivery After Pancreatectomy
RECRUITING
NCT05934487
PROACTIVE-HF-2 Trial Heart Failure NYHA Class II and III
RECRUITING
NCT07603258
Access-H20: Sensor-driven Smart Faucet Related Study
COMPLETED
NCT07110337
Diagnosing Epilepsy To EffeCT Change
RECRUITING
NCT07492797
Accessible Remote Rehabilitation System for Real-Time Biomechanical Monitoring
NOT_YET_RECRUITING
NCT07586098
AI-assisted Diagnosis, Triage and Assessment of Hearing Loss and Tinnitus
NOT_YET_RECRUITING
Related PubMed Literature
PMID: 39977258
Priorities for medical device regulatory approval: a report from the European Society of Cardiology Cardiovascular Round Table.
European heart journal (2025)
PMID: 37288633
[Roadmap of Medical Device for Implanted Brain-computer Interface].
Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation (2023)
PMID: 36476364
ScanMedicine: An online search system for medical innovation.
Contemporary clinical trials (2023)
PMID: 29988408
Regulation of Neurological Devices and Neurointerventional Endovascular Approaches for Acute Ischemic Stroke.
Frontiers in neurology (2018)
Other Devices by Penumbra, Inc.
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.