Cleared Traditional

K243458 - HydroPICC 4Fr Single Lumen Marked catheter

Also marketed or referenced as:
HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001302) HydroPICC 4Fr Single Lumen Marked catheter - Maximal Barrier kit (70001304) HydroPICC 5Fr Dual Lumen Marked catheter, 130 cm guidewire - Basic Kit (70002301) HydroPICC 5Fr Dual Lumen Marked catheter, 70 cm guidewire - Basic Kit (70002302) HydroPICC 5Fr Dual Lumen Marked catheter - Maximal Barrier kit (70002304) Hydr

K243458 is an FDA 510(k) clearance for HydroPICC 4Fr Single Lumen Marked catheter, manufactured by Access Vascular, Inc.. The device is a Class 2 General Hospital device with product code LJS cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K243458 · Access Vascular, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
266d
Days
Class 2
Risk

K243458 is an FDA 510(k) clearance for the HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (700.... Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Access Vascular, Inc. (Ballerica, US). The FDA issued a Cleared decision on August 1, 2025 after a review of 266 days - an extended review cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Access Vascular, Inc. devices

FDA 510(k) Submission Details - K243458

510(k) Number K243458 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2024
Decision Date August 01, 2025
Days to Decision 266 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
137d slower than avg
Panel avg: 129d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LJS Device Classification - Class 2, Special Controls

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 193
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K243458.
Neonav ECG Tip Location System
K260929 · Navi Medical Technologies · Apr 2026
BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology
K252373 · Spectrum Vascular · Dec 2025
PM2™ System with ECGuide™ Connector
K252792 · Piccolo Medical, Inc. · Nov 2025
Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM)
K251212 · Access Vascular, Inc. · Jul 2025
PM2+ System and SmartPICC Stylet
K243484 · Piccolo Medical, Inc. · May 2025
pilot TLS
K241587 · Vygon Corporation · Feb 2025