# K042553: Biocardia Morph Universal Deflectable Guide Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Biocardia, Inc.
- Decided: Feb 17, 2005 after 150 days
- Product code: DQY (Catheter, Percutaneous)
- Device class: 2
- Regulation: 21 CFR 870.1250
- 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 K931794 (1994). 6 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012749: Biocardia Universal Deflectable Guide Catheter, Model 000664, Biocardia, Inc. (2002)
- 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
- K192774: BioCardia 8F Morph DNA Deflectable Guide Catheter (2020), 1 descendant of its own
- K242169: Morph DNA Steerable Introducer Sheath (2024), 0 descendants of its own
- K090999: Biocardia Morph Sheath Guide (2009), 0 descendants of its own

## Indications for use
The BioCardia Morph Universal Deflectable Guide Catheter is intended to provide a pathway through which medical instruments, such as balloon dilatation catheters, guidewires, or other therapeutic devices may be introduced into the peripheral vasculature or chambers and coronary vasculature of the heart.

Source page: https://510kreport.com/device/K042553
Methodology: https://510kreport.com/methodology