Home › Device types › QJP
Catheter, Percutaneous, Neurovasculature
FDA product code QJP · Class 2 · Cardiovascular
278
Registered devices
1,858
Adverse events
7
Recalls
103
510(k) clearances
Devices with this code
FUBUKI XF — ASAHI INTECC CO., LTD.RistTM — Micro Therapeutics, Inc.Millipede 088 Access Catheter — PERFUZE LIMITEDEXCELSIOR XT-27 Flex — Stryker CorporationStellar Guide Catheter — BALT USA LLCMarblehead Medical — MARBLEHEAD MEDICAL LLCAXS VECTA 46 — Stryker CorporationStellar Guide Catheter — BALT USA LLCCEREGLIDE — Cerenovus, Inc.Stellar Guide Catheter — BALT USA LLCAXS VECTA 74 — Stryker Corporation6F Wallaby Long Sheath — Shanghai Wallaby Medical Technologies Co., Inc.Benchmark MAX System — PENUMBRA, INC.MIDWAY — PENUMBRA, INC.FUBUKI XF-R — ASAHI INTECC CO., LTD.pNOVUS 21 Microcatheter — PHENOX LIMITED8F Base Camp System 2.0 90cm — ROUTE 92 MEDICALpNOVUS 21 Microcatheter (160cm) — PHENOX LIMITEDMarblehead Medical — MARBLEHEAD MEDICAL LLCACCESS25 Delivery Microcatheter — PENUMBRA, INC.AXS VECTA 74 — Stryker CorporationEXCELSIOR XT-27 — Stryker CorporationCarrier™ Delivery Catheter — BALT USA LLCSAYA 86 — ASAHI INTECC CO., LTD.
Recent recalls
| Date | Firm | Reason |
|---|---|---|
| 2025-01-16 | Scientia Vascular, Inc. | Due to manufacturing non-conformance that resulted in channels in the seal on the packaging pouch. As a result, this could potential create a breach in the ster |
| 2024-08-30 | Stryker Neurovascular | Stryker Neurovascular has observed that devices with Out of United States (OUS) approved Instructions for Use (IFU) and Packaging Labels (pouch and carton), dif |
| 2024-04-23 | Stryker Neurovascular | Neurovascular devices did not meet the minimum sample size required for endotoxin testing during manufacturing processes and are out of compliance with the AAMI |
| 2024-03-08 | ROUTE 92 MEDICAL INC | Their is the potential for distal tip separation at the proximal marker band of the delivery catheters |
| 2024-03-08 | ROUTE 92 MEDICAL INC | Their is the potential for distal tip separation at the proximal marker band of the delivery catheters. |
| 2024-02-02 | Medos International Sarl | Medos has received an increase in complaints for CEREBASE DA Guide Sheath with reports of fractures at the distal end, which may result in surgical procedural d |
| 2023-12-06 | Stryker, Inc. | The microcatheter IFU contains an intended use that has not been evaluated by the FDA. |
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