Biocardia, Inc.
Sunnyvale, CA, US
BIOCARDIA, INC. appears in FDA device records in Sunnyvale, CA. FDA records list 6 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 3 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 6 510(k) clearances for Biocardia, Inc. between 2002 and 2024. The busiest year on record is 2002, with 1. The most recent is 2024, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2002 | 1 |
| 2005 | 1 |
| 2009 | 1 |
| 2019 | 1 |
| 2020 | 1 |
| 2024 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K242169 | Morph DNA Steerable Introducer Sheath | DYB | Substantially Equivalent | |
| K192774 | BioCardia 8F Morph DNA Deflectable Guide Catheter | DQY | Substantially Equivalent | |
| K190941 | BioCardia 8.5 F Avance Steerable lntroducer | DYB | Substantially Equivalent | |
| K090999 | BIOCARDIA MORPH SHEATH GUIDE | DYB | Substantially Equivalent | |
| K042553 | BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER | DQY | Substantially Equivalent | |
| K012749 | BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664 | DQO | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3003610571 | 3003610571 | BIOCARDIA, INC. | 320 Soquel Way, Sunnyvale, CA 94085 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-1302-2014 | Morph AccessPro Steerable Introducer; 6F Introducer, 90 cm working length: Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other therapeutic devices that may be introduced into the peripheral vasculature. | Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event. | Class II | Terminated | |
| Z-1301-2014 | Morph AccessPro Steerable Introducer; 6F Introducer, 45 cm working length Single use only. BioCardia, Inc. San Carlos, CA 94070 BioCardia Morph AccessPro is intended to provide a pathway through medical instruments cush as balloon dilation catheters, guidewires or other therapeutic devices that may be introduced into the peripheral vasculature. | Firm discovered the potential for particulates in the inner lumen of Morph Access Pro Steerable Introducer, which could result in am embolic event. | Class II | Terminated | |
| Z-0991-2014 | MORPH ACCESSPRO Steerable Introducer; 6F introducer, 90 cm working length: Sterile in unopened, undamaged pouch. Sterilized by EtO gas, Non-pyrogenic: BioCardia Inc. San Carlos, CA 94070 Intended to provide a pathway through which medical instruments such as balloon dilation catheters, guidewires and other therapeutic devices may be introduced into the peripheral vasculature. | Tyvek packaging may be worn, causing loss of package integrity. | Class II | Terminated |
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain