# K021704: Vaxcel Picc with Pasv Valve Technology

- Pathway: 510(k) (Special)
- Applicant: Catheter Innovations, Inc.
- Decided: Jun 6, 2002 after 14 days
- Product code: LJS (Catheter, Intravascular, Therapeutic, Long-Term Greater Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5970
- Recalls of this device: 31 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
34 later devices descend from it; 4 cite it directly.
2 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but kept off the family tree
- K036421: PLACEMENT-plus. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K091261: Nmi Picc (2009), 27 descendants of its own
- K093366: Nmi Picc II (2009), 26 descendants of its own
- K121089: Nmi Picc Iii (2012), 23 descendants of its own
- K111906: Xcela Hybrid Picc with Pasv Valve Technology (2011), 14 descendants of its own
- K122882: Nmi Hpicc Iii (2012), 12 descendants of its own

## Recalls of this device
- Mar 14, 2016 · Class II · Z-1985-2016: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC cathet
- Mar 14, 2016 · Class II · Z-1982-2016: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC cathet
- Mar 14, 2016 · Class II · Z-1969-2016: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC cathet
- Mar 14, 2016 · Class II · Z-1971-2016: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC cathet
- Mar 14, 2016 · Class II · Z-1972-2016: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC cathet
- Mar 14, 2016 · Class II · Z-1977-2016: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC cathet
- Mar 14, 2016 · Class II · Z-1975-2016: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC cathet
- Mar 14, 2016 · Class II · Z-1987-2016: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC cathet
- Mar 14, 2016 · Class II · Z-1988-2016: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC cathet
- Mar 14, 2016 · Class II · Z-1973-2016: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC cathet
- Mar 14, 2016 · Class II · Z-1980-2016: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC cathet
- Mar 14, 2016 · Class II · Z-1984-2016: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC cathet
- Mar 14, 2016 · Class II · Z-1966-2016: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC cathet
- Mar 14, 2016 · Class II · Z-1974-2016: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC cathet
- Mar 14, 2016 · Class II · Z-1968-2016: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC cathet
- Mar 14, 2016 · Class II · Z-1976-2016: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC cathet
- Mar 14, 2016 · Class II · Z-1979-2016: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC cathet
- Mar 14, 2016 · Class II · Z-1986-2016: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC cathet
- Mar 14, 2016 · Class II · Z-1970-2016: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC cathet
- Mar 14, 2016 · Class II · Z-1967-2016: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC cathet
- Mar 14, 2016 · Class II · Z-1983-2016: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC cathet
- Mar 14, 2016 · Class II · Z-1978-2016: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC cathet
- Mar 14, 2016 · Class II · Z-1981-2016: PICC catheters that contain valve(s) manufactured prior to July 15, 2014 lack a manufacturing specification change that reduces the incidence of hemolysis during blood sampling through the PICC cathet
- Nov 22, 2004 · Not classified · Z-0403-05: Catheter separation immediately distal to the nose of the suture wing.
- Nov 22, 2004 · Not classified · Z-0407-05: Catheter separation immediately distal to the nose of the suture wing.
- Nov 22, 2004 · Not classified · Z-0408-05: Catheter separation immediately distal to the nose of the suture wing.
- Nov 22, 2004 · Not classified · Z-0409-05: Catheter separation immediately distal to the nose of the suture wing.
- Nov 22, 2004 · Not classified · Z-0404-05: Catheter separation immediately distal to the nose of the suture wing.
- Nov 22, 2004 · Not classified · Z-0405-05: Catheter separation immediately distal to the nose of the suture wing.
- Nov 22, 2004 · Not classified · Z-0410-05: Catheter separation immediately distal to the nose of the suture wing.
- Nov 22, 2004 · Not classified · Z-0406-05: Catheter separation immediately distal to the nose of the suture wing.

## Indications for use
The Vaxcel PICC with PASV Valve Technology is indicated for use in establishing peripheral access to the central venous system for administration of fluids including, but not limited to, hydration agents, antibiotics, chemotherapy, analgesics, nutritional therapy and blood products. It is also indicated for blood specimen withdrawal. This product is effective for central venous access in adults, children and infants who require intravenous (IV) therapy.

Source page: https://510kreport.com/device/K021704
Methodology: https://510kreport.com/methodology