HydroPICC 5F Dual Lumen Catheter— 510(k) K213550
Substantially EquivalentAccess Vascular, Inc.
FDA 510(k) clearance K213550 for HydroPICC 5F Dual Lumen Catheter, Substantially Equivalent on 2022-05-04. Applicant: Access Vascular, Inc.. Device class: 2.
Clearance details
- Applicant
- Access Vascular, Inc.
- Product code
- Code LJS
- Device class
- Class 2
- Regulation
- 21 CFR 880.5970
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Bedford, MA, US
Recent devices under product code LJS
view all- K260929 — Neonav ECG Tip Location System
- K252373 — BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology +6 more
- K252792 — PM2 System with ECGuide Connector
- K243458 — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301) +5 more
- K251212 — Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM)
More clearances from Access Vascular, Inc.
view allAdverse events under product code LJS
product code LJS- Death
- 31
- Injury
- 2,791
- Malfunction
- 18,374
- Other
- 5
- Total
- 21,201
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 K213550
K-number listed on FDA's recall record- Z-0114-2024 — HydroPICC 5Fr Dual Lumen, 80cm guidewire - Basic Kit, Product Model Number 80002002
- Z-0115-2024 — HydroPICC 5Fr Dual Lumen Maximal Barrier Kit, Product Model Number 80002004
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K213550.
Data sourced from openFDA. This site is unofficial and independent of the FDA.