Concentric Medical, Inc.
Concentric Medical, Inc. holds FDA 510(k) medical device clearances, first cleared 2001, most recent 2018, with 5 FDA device recalls on record.
Top product codes for Concentric Medical, Inc.
FDA recalls by Concentric Medical, Inc.
- Z-0116-2016 — Distal Access Catheters - 044 - 115 cm: Finished Good Number 90960-001 / REF 90960. Cardiology: The Distal Access Catheter is indicated for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter, or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vasculatuure systems.
- Z-2598-2014 — Merci Retriever Intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stoke. Merci Retrievers are also indicated for use in the retrieval of foreign bodies misplaced during interventional radiological procedures in the neuro, peripheral and coronary vasculature.
- Z-0528-2015 — Trevo Pro 4 Stent Retriever, Model number 80021; U.S. Indications for use: The Trevo Retriever is intended to restore blood flow in the neurovasculature by removing thrombus in patients experiencing ischemic stroke within 8 hours of symptom onset. Patients who are ineligible for intravenous tissue plasminogen activator (IV t-PA) or who fail IV t-PA therapy are candidates for treatment.
- Z-0525-2015 — Distal Access Catheter: Model Numbers: 90121, 90130, 90131, 90160. The Distal Access Catheter is intended for use in facilitating the insertion and guidance of an occlusion catheter, infusion catheter or other appropriate microcatheter into a selected blood vessel in the peripheral, coronary and neuro vascular systems.
- Z-0655-2013 — FlowGate Balloon Guide Catheter; Manufactured by Concentric Medical, Mountain View, CA. FlowGate" Balloon Guide Catheters are coaxial-lumen, braid-reinforced, variable stiffness catheters with a radiopaque marker on the distal end and a bifurcated luer hub on the proximal end. A balloon is flush mounted on the distal end. FlowGate" Balloon Guide Catheters are indicated for use in facilitating the insertion and guidance of an intravascular catheter into a selected blood vessel in the peripheral and neurovascular systems. The balloon provides temporary vascular occlusion during these and other angiographic procedures. The Balloon Guide Catheter is also indicated for use as a conduit for Retrieval devices.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Concentric Medical, Inc.
- K173352 — Trevo Pro Vue Retriever and Trevo XP Pro Vue Retriever (Trevo Retriever)
- DEN150049 — Modified Trevo ProVue Retriever, Trevo XP ProVue Retriever 4x20mm, Trevo XP ProVue Retriever 3x20mm, Trevo XP ProVue Retriever 6x25mm, Trevo XP ProVue Retriever 4x30mm
- K150616 — Trevo XP ProVue Retriever (4x30mm)
- K143077 — Trevo XP ProVue Retriever (6X25mm)
- K133177 — MODIFIED HD GUIDE CATHETER
- K133464 — MODIFIED TREVO PROVUE RETRIEVER
- K132641 — MODIFIED TREVO PROVUE RETRIEVER
- K131437 — MODIFIED CONCENTRIC MICROCATHETER
- K131492 — MODIFIED FLOWGATE BALLOON GUIDE CATHETER
- K122581 — MODIFIED BALLOON GUIDE CATHETER MODEL 90253, 90254
- K122478 — MODIFIED TREVO RETRIEVER
- K120961 — TREVO RETRIEVER
- K112404 — CONCENTRIC BALLOON GUIDE CATHETER
- K113260 — MODIFIED CONCENTIRC MICROCATHETER
- K111619 — MODIFIED CONCENTRIC MICROCATHETER
- K110483 — MODIFIED HD GUIDE CATHETER
- K093610 — MODIFIED RETRIEVER (MODIFIED, LINE EXTENSION), MODELS 90152, 90153
- K102657 — CONCENTRIC BALLOON GUIDE CATHETER
- K092298 — MODIFICATION TO MODIFIED HD GUIDE CATHETER
- K091703 — HD GUIDE CATHETER, MODEL 90019, 90022, 90023, 90120, 90121, 90130, 90131
- K091961 — MODIFIED CONCENTRIC MICROCATHETER, MODEL 90047
- K090335 — HD GUIDE CATHETER
- K090085 — MERCI RETRIEVER, MODELS 90050, 90060, 90066, 90070, 90110, 90111, 90112, 90113
- K082034 — MODIFICATION TO MERCI RETRIEVER
- K080583 — MODIFIED HD GUIDE CATHETER
- K081305 — MERCI RETRIEVER
- K072796 — MEERCI RETRIEVER, CONCENTRIC MICROCATHETER, MODELS 90050, 90060, 90065, 90066, 90070,90092, 90043, 90044
- K071172 — MODIFIED MERCI RETRIEVER, MODEL 90060
- K070521 — MODIFIED MERCY RETRIEVER, MODEL 90070
- K063774 — MODIFICATION TO MERCI RETRIEVER, MODELS X5 AND X6
- K062046 — MODIFIED MERCI RETRIEVER, MODEL 90050
- K061059 — MODIFIED MERCI RETRIEVER, MODEL 90092
- K051838 — MODIFIED CONCENTRIC RETRIEVER, MODEL 90039
- K050470 — CONCENTRIC EMBOLIC PEARLS
- K033736 — MERCI RETRIEVER, MODELS 90065, 90066
- K040745 — MODIFIED CONCENTRIC RETRIEVER, MODEL 90038
- K040700 — CONCENTRIC RETRIEVER X5, MODEL 90035; CONCENTRIC RETRIEVER X6, MODEL 90037
- K030476 — MODIFIED CONCENTRIC RETRIEVER, MODEL 90037
- K021899 — CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90072
- K010954 — CONCENTRIC BALLOON GUIDE CATHETER, MODEL 90031
- K003410 — CONCENTRIC RETRIEVER, MODEL 90030
- K003084 — CONCENTRIC HYDROPHILIC GUIDEWIRE, MODELS 90011, 90012
- K003086 — CONCENTRIC MICRO CATHETER, MODELS 90001 TO 90008
- K003880 — CONCENTROC HD GUIDE CATHETER, MODELS 90017 (4F), 90019 (5F), 90021 (6F), 90022 (7F), 90023 (8F), 90024 (9F)
- K003085 — CONCENTRIC GUIDE CATHETER, MODELS 90018, 90020
Data sourced from openFDA. This site is unofficial and independent of the FDA.