LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER— 510(k) K051395
Substantially EquivalentVascular Solutions, Inc.
FDA 510(k) clearance K051395 for LANGSTON DUAL LUMEN PRESSURE MONITORING CATHETER, Substantially Equivalent on 2005-06-24. Applicant: Vascular Solutions, Inc.. Device class: 2.
Clearance details
- Applicant
- Vascular Solutions, Inc.
- Product code
- Code DQO
- Device class
- Class 2
- Regulation
- 21 CFR 870.1200
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Minneapolis, MN, US
Recent devices under product code DQO
view all- K261455 — Arterial Pressure Monitoring Set/Tray
- K252702 — Bioptimal Pulmonary Artery Monitoring Catheter (TD2502NF, TD2502NGF, TD2502NDF, TD2502NCF, TD2502NCGF, TD2502NDGF, TD2502NDCF, TD2502NDCGF, TD2502NXCF, TD2502NDXF, TD2502NXCGF, TD2502NDXGF, TD2502NDXCF, TD2502NDXCGF, TD2502-110NF, TD2502-110NGF, TD2502-110NDF, TD2502-110NCF, TD2502-110NDGF, TD2502-110NDCF, TD2502-110NCGF, TD2502-110NDCGF, TD2502-110NXF, TD2502-110NXGF, TD2502-110NDXF, TD2502-110NXCF, TD2502-110NDXGF, TD2502-110NDXCF ,TD2502-110NXCGF, TD2502-110NDXCGF, TD2602NF, TD2602N
- K254278 — Arterial Pressure Monitoring Set/Tray
- K250751 — DualView Catheter
- K242966 — Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter
More clearances from Vascular Solutions, Inc.
view allAdverse events under product code DQO
product code DQO- Death
- 35
- Injury
- 993
- Malfunction
- 1,772
- Other
- 5
- Total
- 2,805
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K051395
K-number listed on FDA's recall record- Z-0110-2021 — Langston Dual Lumen Catheter
- Z-0111-2021 — Langston Dual Lumen Catheter.
- Z-0112-2021 — Langston Dual Lumen Catheter.
- Z-1747-2020 — Langston Dual Lumen Catheter 6F Model 5540. For delivery of contrast medium in angiographic studies
- Z-1981-2014 — Langston Dual Lumen Catheters, 6Fr, REF 5550 and 5540. The Vascular Solutions Langston Dual Lumen Pressure Monitoring catheter is used as a pressure measurement catheter and for delivery of contrast media during angiographic studies.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K051395.
Data sourced from openFDA. This site is unofficial and independent of the FDA.