Atlas FDA

HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); 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

FDA 510(k) clearance K243458 · decided 2025-08-01

Clearance details

K-number
K243458
Device name
HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001301); 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
Applicant
Access Vascular, Inc.
Decision
Substantially Equivalent
Date received
2024-11-08
Decision date
2025-08-01
Days to decision
266 days
Clearance type
Traditional
Product code
LJS
Device class
2
Regulation number
880.5970
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Ballerica, MA, US
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
Neonav ECG Tip Location System (K260929)Navi Medical Technologies2026-04-17
BioFlo Hybrid PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology and PASV Valve Technology; BioFlo PICC with ENDEXO Technology; BioFlo Midline Catheter; Xcela Power Injectable PICC; Xcela PICC with PASV Valve Technology; Xcela Hybrid PICC with PASV Valve Technology (K252373)Spectrum Vascular2025-12-16
PM2™ System with ECGuide™ Connector (K252792)Piccolo Medical, Inc.2025-11-17
Dual Lumen 5Fr HydroPICC Catheter (PICC-251CM) (PICC-251CM); Dual Lumen 5Fr HydroPICC Catheter (PICC-252CM) (PICC-252CM) (K251212)Access Vascular, Inc.2025-07-01
PM2+ System and SmartPICC Stylet (K243484)Piccolo Medical, Inc.2025-05-29
pilot TLS (K241587)Vygon Corporation2025-02-26
Neonav ECG Tip Location System (K241910)Navi Medical Technologies2025-01-19
HydroPICC 4Fr Single Lumen Marked catheter, 130 cm guidewire - Basic Kit (70001201); HydroPICC 4Fr Single Lumen Marked catheter, 70 cm guidewire - Basic Kit (70001202); HydroPICC 4Fr Single Lumen Marked catheter, Maximal Barrier kit (70001204); HydroPICC 4Fr Single Lumen Marked catheter, Mobile Maximal Barrier Kit (90001204) (K243941)Access Vascular, Inc.2025-01-17
PM2 System and ECGuide Connector (K240486)Piccolo Medical, Inc.2024-09-08
CATHTONG III Tapered PICC Catheter (K233149)L&Z Us, Inc.2023-12-01
L-Cath™ Single and Dual Lumen Catheters, L-Cath™ Midline Catheters (K230669)Argon Medical Devices2023-11-30
CATHTONG™ II PICC Catheter (K232571)L&Z Us, Inc.2023-09-22

Recalls involving this device

No recalls on record reference this clearance.