# K012749: Biocardia Universal Deflectable Guide Catheter, Model 000664

- Pathway: 510(k) (Traditional)
- Applicant: Biocardia, Inc.
- Decided: Jan 24, 2002 after 161 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: 2 generations back to K931794 (1994). 5 ancestors in all.
37 later devices descend from it; 3 cite it directly.
3 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K961280: Scimed 6-10 F Triguide Guide Catheters 6F,7F,8F,9F & 10F, Scimed Life Systems, Inc. (1996) Summary page 1.
- K971034: Usci Mainstay Guiding Catheter, C.R. Bard, Inc. (1997) Summary page 1.
- K974683: Naviport Deflectable Tip Guiding Catheter, Cardima, Inc. (1999) Summary page 1.

## Most influential descendants
- K040922: Venture Wire Control Catheter (2004), 31 descendants of its own
- K042910: Venture Wire Control Catheter, Model WCC (2004), 30 descendants of its own
- K061843: Venture Wire Control Catheter, Model WCC (2006), 28 descendants of its own
- K080987: Bridgepoint Medical Stingray Device and Accessories (2009), 24 descendants of its own
- K101591: Stingray Orienting Balloon Catheter (2010), 14 descendants of its own

## Indications for use
The BioCardia Universal Deflectable Guide Catheter is intended to serve as a conduit for access in the chambers and coronary vasculature of the heart

Source page: https://510kreport.com/device/K012749
Methodology: https://510kreport.com/methodology