# K090999: Biocardia Morph Sheath Guide

- Pathway: 510(k) (Traditional)
- Applicant: Biocardia, Inc.
- Decided: Apr 15, 2009 after 7 days
- Product code: DYB (Introducer, Catheter)
- Device class: 2
- Regulation: 21 CFR 870.1340
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K893658 (1989). 43 ancestors in all.
No later device cites it as a predicate yet.
0 of 44 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K042553: Biocardia Morph Universal Deflectable Guide Catheter, Biocardia, Inc. (2005) Summary page 1.
- K043489: Enpath Deflectable Catheter, Enpath Medical Incorporated (2005) Summary page 1.
- K080415: Device Modification to Pinnacle Destination Peripheral Guiding Sheath, Terumo Medical Corp. (2008) Summary page 1.

## Recalls of this device
- Mar 3, 2014 · Class II · Z-1301-2014: Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event.
- Mar 3, 2014 · Class II · Z-1302-2014: Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event.
- Feb 7, 2014 · Class II · Z-0991-2014: Tyvek packaging may be worn, causing loss of package integrity.

## Indications for use
The BioCardia Morph® Sheath Guide 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.

Source page: https://510kreport.com/device/K090999
Methodology: https://510kreport.com/methodology