# K113737: Surefire Guide Sheath

- Pathway: 510(k) (Special)
- Applicant: Surefire Medical, Inc.
- Decided: Feb 23, 2012 after 65 days
- Product code: DQO (Catheter, Intravascular, Diagnostic)
- Device class: 2
- Regulation: 21 CFR 870.1200
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K003105 (2001). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K110459: Surefire Infusion Catheter System, Surefire Medical, Inc. (2011)

## Indications for use
The SUREFIREV GUIDE SH4EATH is intended for use in angiographic procedures. It delivers radiopaque media and therapeutic agents to selected sites in the peripheral vascular system.

Source page: https://510kreport.com/device/K113737
Methodology: https://510kreport.com/methodology