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510(k) Data Aggregation
K Number
K242169Device Name
Morph DNA Steerable Introducer Sheath
Manufacturer
Date Cleared
2024-08-23
(30 days)
Product Code
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
BioCardia
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The Morph DNA Steerable Introducer Sheath 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.
Device Description
The Morph DNA Steerable Introducer Sheath is sterile, single-use bidirectional deflectable catheter with an ergonomic handle that has an integrated swiveling hemostasis valve. When the handle is fully actuated, the distal tip deflects to a nominal angle in either of two directions based on the diameter and the working length of the catheter. The catheter tip includes a fluoroscopic marker to help visualize the tip location and vent holes to facilitate aspiration and flushing of the lumen. The Morph DNA handle includes a brake to hold the deflection angle, an integrated hemostasis valve with a swiveling sideport, and 3-way stopcock. Devices are packaged with a compatible dilator on a plastic backing card within a sealed Tyvek pouch, all of which are contained in a product box.
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K Number
K192774Device Name
BioCardia 8F Morph DNA Deflectable Guide Catheter
Manufacturer
Date Cleared
2020-01-07
(99 days)
Product Code
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
BioCardia
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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.
Device Description
The BioCardia 8F Morph® DNA Deflectable Guide Catheter is a sterile, single use, bi-directional deflectable guide catheter. When the handle is fully actuated, the distal tip deflects to a minimum 135° arc in either of two directions with a nominal curve distance of 30 mm. The catheter tip includes a fluoroscopic marker to help visualize the tip location. The Morph DNA handle includes a brake to hold the deflection angle, an integrated hemostasis valve with a swiveling sideport, and 3-way stopcock.
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K Number
K190941Device Name
BioCardia 8.5 F Avance Steerable lntroducer
Manufacturer
Date Cleared
2019-05-06
(26 days)
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
BioCardia, Inc
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BioCardia 8.5 F Avance™ Steerable Introducer is intended for introducing various cardiovascular catheters into the heart, including the left side of the heart through the interatrial septum.
Device Description
The BioCardia 8.5 F Avance™ Steerable Introducer (Avance) is a sterile, single use, bidirectional introducer. When the handle is fully actuated, the distal tip deflects to a nominal 180° arc in either of two directions with a nominal curve distance as indicated by the product label. The introducer tip includes a fluoroscopic marker to help visualize the tip location and vent holes to facilitate aspiration and flushing of the lumen. The Avance handle includes a brake to hold the deflection angle, an integrated hemostasis valve with a swiveling sideport, and 3-way stopcock.
Avance includes a dilator with a pre-curved, tapered tip which extends up to 2.5 cm beyond Avance to facilitate transseptal placement. The dilator hub snaps into the Avance hemostasis valve and can accommodate a guidewire diameter of up to .038".
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K Number
K090999Device Name
BIOCARDIA MORPH SHEATH GUIDE
Manufacturer
Date Cleared
2009-04-15
(7 days)
Product Code
Regulation Number
870.1340Why did this record match?
Applicant Name (Manufacturer) :
BIOCARDIA, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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.
Device Description
The BioCardia Morph® Sheath Guide is a single lumen steerable catheter introducer. It is designed to be delivered percutaneously with the use of an internal dilator and advanced to a desired location within the vasculature to facilitate delivery of therapeutic catheters. Steering of the device is accomplished by rotation of a knob on the handle which deflects the distal tip of the catheter shaft. The BioCardia Morph Sheath Guide is supplied with a dilator and includes a hemostasis valve through which the dilator, guidewires, and devices may be passed while minimizing blood loss.
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K Number
K042553Device Name
BIOCARDIA MORPH UNIVERSAL DEFLECTABLE GUIDE CATHETER
Manufacturer
Date Cleared
2005-02-17
(150 days)
Product Code
Regulation Number
870.1250Why did this record match?
Applicant Name (Manufacturer) :
BIOCARDIA, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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.
Device Description
Not Found
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K Number
K012749Device Name
BIOCARDIA UNIVERSAL DEFLECTABLE GUIDE CATHETER, MODEL 000664
Manufacturer
Date Cleared
2002-01-24
(161 days)
Product Code
Regulation Number
870.1200Why did this record match?
Applicant Name (Manufacturer) :
BIOCARDIA, INC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
The BioCardia Universal Guide Catheter is intended to serve as a conduit for access into the chambers of the heart and coronary vasculature of the heart.
Device Description
BioCardia Universal Deflectable Guide Catheter
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