# K030571: Acuvance Plus Safety IV Catheter, Protectiv Plus Safety IV Catheter, Optiva IV Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Ethicon Endo-Surgery, Inc.
- Decided: Mar 28, 2003 after 32 days
- Product code: FOZ (Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days)
- Device class: 2
- Regulation: 21 CFR 880.5200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
31 later devices descend from it; 2 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) ACUVANCE PLUS Safety IV Catheter: named in the summary without a submission number
- (no number) PROTECTIV PLUS Safety IV Catheter: named in the summary without a submission number
- (no number) OPTIVA IV Catheter: named in the summary without a submission number

## Most influential descendants
- K050114: Supercath Z3V (2005), 30 descendants of its own
- K081953: Supercath 5 (2009), 28 descendants of its own
- K093546: Supercath 5 Model SP120-XX-XX, SP125-XX-XX (2009), 27 descendants of its own
- K110443: BD Insyte Autoguard BC (2011), 21 descendants of its own
- K140504: Accucath BC Intravascular Catheter System (2014), 7 descendants of its own

## Indications for use
ACUVANCE PLUS Safety Tv Catheter: A properly placed 1.V. catheter provides access to a vein or art~ry. The I.V. Catheter System is designed for single use and has a needlestick protection feature. The risk of accidental needlesticks is reduced by a self-blunting needle system activated automatically as the catheter is threaded into the vessel. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of therapy. 14 to 22 gauge catheters may be used with power injector up to 300 psi. PROTECTN PLUS Safety IV Catheter The PROTECTN PLUS Safety I.V. Catheter is designed for single use. A properly placed I.V. catheter provides access to a vein or mery. The PROTECTIV PLUS Safety I-V. Catheter is designed to minimize inadvertent needlesticks. During catheter insertion, a needle guard can be locked over the introducer needle. These catheters may be used for any patient population with consideration given to patient size, appropriaceness for the solution being infused, and duration of therapy. 16G to 24G catheters may be used w i h power injectors up to 300 psi. OFTIVA IV Catheter: The OPTIVA I.V. Catheter is designed for single w e. A properly placed I.V. catheter provides access to a vein or artery. These catheters may be used for any patient population with consideration given to patient size, appropriateness for the solution being infused, and duration of rhcrapy. 16G to 24G catheters may be used with power injectors up co 300 psi.

Source page: https://510kreport.com/device/K030571
Methodology: https://510kreport.com/methodology