# K081846: Grebset Micro-Introducer Kit, Models 7950, 7951

- Pathway: 510(k) (Traditional)
- Applicant: Vascular Solutions, Inc.
- Decided: Jan 28, 2009 after 212 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K810412 (1981). 11 ancestors in all.
No later device cites it as a predicate yet.
2 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K073585: Innerchange Micro-Introducer Catheter, Models 7900, 7901, 7902, 7903, 7904 and 7905, Vascular Solutions, Inc. (2008) Summary page 1.
- (no number) AccuStick II: named in the summary without a submission number
- (no number) Neff Percutaneous Access Set: named in the summary without a submission number

## Recalls of this device
- Jan 12, 2017 · Class II · Z-1250-2017: Four Lots of GrebSet Micro-introducer Kits, model 7941, contain guidewires that have a shelf life shorter than the kit expiration date.

## Indications for use
The GrebSet micro-introducer kit is intended to facilitate the percutaneous placement of guidewires in the vascular system and for delivery of contrast media to vascular sites.

Source page: https://510kreport.com/device/K081846
Methodology: https://510kreport.com/methodology