Atlas FDA

VAXCEL PICC WITH PASV VALVE TECHNOLOGY

FDA 510(k) clearance K021704 · decided 2002-06-06

Clearance details

K-number
K021704
Device name
VAXCEL PICC WITH PASV VALVE TECHNOLOGY
Applicant
Catheter Innovations, Inc.
Decision
Substantially Equivalent
Date received
2002-05-23
Decision date
2002-06-06
Days to decision
14 days
Clearance type
Special
Product code
LJS
Device class
2
Regulation number
880.5970
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
Salt Lake City, UT, US
Third-party review
No
Expedited review
No

+ Add to Predicate Builder ◉ Watch Catheter Innovations

Need this as data, not a web page?

Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.

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
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 (K243458)Access Vascular, Inc.2025-08-01
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

Recalls involving this device

RecordFirmDate
VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen. Catalog #45-450, UPN recall (Z-0403-05)Boston Scientific Corporation2005-01-20
VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen, sold in a kit, Catal recall (Z-0404-05)Boston Scientific Corporation2005-01-20
VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen, sold in a kit, Catal recall (Z-0405-05)Boston Scientific Corporation2005-01-20
VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen, sold in kits, Catalo recall (Z-0406-05)Boston Scientific Corporation2005-01-20
VAXCEL PASV Peripherally Inserted Central Catheter, 3F, single lumen: CUSTOM KIT - GENESIS recall (Z-0407-05)Boston Scientific Corporation2005-01-20
PASV PICC CUSTOM KIT, 3F, single lumen - CHILDREN''S HEALTHCARE OF ATLANTA, Catalog # 60M1 recall (Z-0408-05)Boston Scientific Corporation2005-01-20
VAXCEL WITH PASV PICC, 3F, single lumen. CUSTOM KIT - UNIVERSITY OF NEW MEXICO HOSPITAL, C recall (Z-0409-05)Boston Scientific Corporation2005-01-20
PASV PICC, 3F, single lumen, CUSTOM KIT - VANDERBILT UNIVERSITY MEDICAL CENTER. Catalog #6 recall (Z-0410-05)Boston Scientific Corporation2005-01-20