# K945070: Versasae Plastic Cannula- 11 Gauge

- Pathway: 510(k) (Traditional)
- Applicant: Imed Corp.
- Decided: Jan 13, 1995 after 91 days
- Product code: FPA (Set, Administration, Intravascular)
- Device class: 2
- Regulation: 21 CFR 880.5440
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 3 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K962801: Safe Mate I.V. Extension Sets (1996), 0 descendants of its own
- K962802: Safe Mate I.V. Fluid Delivery Sets (1996), 0 descendants of its own
- K961328: Bec Shrouded Plastic Cannula (1996), 0 descendants of its own

## Recalls of this device
- Jun 30, 2017 · Class II · Z-3030-2017: Punctures in blister packaging that was detected during the packaging process.

Source page: https://510kreport.com/device/K945070
Methodology: https://510kreport.com/methodology