HydroPICC (PICC-142)— 510(k) K193015

Name: FDA 510(k) clearance K193015
Creator: U.S. Food and Drug Administration
Published: 2020-02-20

Substantially Equivalent

Access Vascular, Inc.

FDA 510(k) clearance K193015 for HydroPICC (PICC-142), Substantially Equivalent on 2020-02-20. 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: 2019-10-29
Decision date: 2020-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Bedford, MA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LJS

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More clearances from Access Vascular, Inc.

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K244059 — HydroMID 5F Dual Lumen Midline Catheter - Basic Kit (70006102) +2 more2025-03-27
K243941 — HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201) +3 more2025-01-17
K220772 — HydroMID 4F Single Lumen Midline Catheter2022-12-07
K213550 — HydroPICC 5F Dual Lumen Catheter2022-05-04
K203069 — HydroMID2021-02-08

Adverse 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, 2020-01-01 through 2026-04-23. 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 K193015

K-number listed on FDA's recall record

Z-1605-2023 — HydroPICC 4Fr Single Lumen Catheter, Maximal Barrier Kit, Model Number 80001004Class II·Ongoing·Access Vascular, Inc·20230303
Z-1130-2023 — HydroPICC 4Fr Single Lumen, 80cm Guidewire - Basic Kit, Model Number 80001002Class II·Ongoing·Access Vascular, Inc·20221216
Z-1131-2023 — HydroPICC 4Fr Single Lumen, 130cm Guidewire - Basic Kit, Model Number 80001001Class II·Ongoing·Access Vascular, Inc·20221216
Z-0199-2023 — Scalpel and StatLock included with HydroPICC Catheter Kit - PICC-142, Peripherally Inserted Central CatheterClass II·Terminated·Access Vascular, Inc.·20210224

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K193015.

Data sourced from openFDA. This site is unofficial and independent of the FDA.