Home › Device types › QJP
Catheter, Percutaneous, Neurovasculature
FDA product code QJP · Class 2 · Cardiovascular
260
Registered devices
1,668
Adverse events
7
Recalls
96
510(k) clearances
Devices with this code
EXCELSIOR XT-27 — Stryker Corporation088 Access System — ROUTE 92 MEDICALCEREGLIDE — Cerenovus, Inc.8F Base Camp system 2.0 80cm — ROUTE 92 MEDICALBranchor X — ASAHI INTECC CO., LTD.CEREGLIDE — Cerenovus, Inc.CEREGLIDE — Cerenovus, Inc.6F Wallaby Long Sheath — Shanghai Wallaby Medical Technologies Co., Inc.Zoom 88 Large Distal Platform — IMPERATIVE CARE, INC.Echo — Stryker CorporationSocrates — SCIENTIA VASCULAR LLCAXS VECTA 71 — Stryker CorporationSOFIA 88 — Microvention, Inc.Carrier™ Delivery Catheter — BALT USA LLCAPRO 45 Intermediate Catheter — Alembic, LLCAPRO 55 Intermediate Catheter — Alembic, LLCMillipede 088 Access Catheter — PERFUZE LIMITEDWallaby 017 Micro Catheter — Shanghai Wallaby Medical Technologies Co., Inc.Stellar Guide Catheter — BALT USA LLCMillipede 088 Access Catheter — PERFUZE LIMITEDStellar Guide Catheter — BALT USA LLCPROWLER — Medos International SàrlStellar Guide Catheter — BALT USA LLCParagon 8F Balloon Guide Cathete — Shanghai Wallaby Medical Technologies Co., Inc.
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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